Company · US
Nobel Biocare AB
FDA 510(k) clearances and medical device recalls filed under this name, 2002 to 2026. Name variants (Inc, Corp, punctuation) are merged.
105510(k) clearances (3 in 12 months)
70recalls (0 in 12 months)
60recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 70 |
| NHA | Abutment, Implant, Dental, Endosseous | 56 |
| DZI | Drill, Bone, Powered | 15 |
| NDP | Accessories, Implant, Dental, Endosseous | 9 |
| LLZ | System, Image Processing, Radiological | 8 |
| ELL | Teeth, Porcelain | 5 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 4 |
| EIH | Powder, Porcelain | 2 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 1 |
| EBW | Controller, Foot, Handpiece And Cord | 1 |
| FZE | Prosthesis, Nose, Internal | 1 |
| MYN | Analyzer, Medical Image | 1 |
| PNP | Dental Abutment Design Software For Dental Laboratory | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 8, 2026 | K253988 | LiteSet Trays Nobel Biocare AB, SE | KCT |
| Aug 6, 2026 | K253999 | Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and No Nobel Biocare AB, SE | NHA |
| Feb 18, 2026 | K252197 | Nobel Biocare S Series Implants Nobel Biocare AB, SE | DZE |
| Aug 25, 2025 | K243834 | NobelZygoma TiUltra Implant system Nobel Biocare AB, SE | DZE |
| Jan 3, 2025 | K240346 | NobelProcera Zirconia Implant Bridge Nobel Biocare AB, SE | NHA |
| Jan 24, 2024 | K233208 | NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium Nobel Biocare AB, SE | NHA |
| Dec 8, 2023 | K231898 | DTX Studio Clinic (4.0) Nobel Biocare AB, SE | LLZ |
| Apr 28, 2023 | K223677 | Titanium Abutment Blank Nobel Biocare N1 TCC Nobel Biocare AB, SE | NHA |
| Mar 28, 2023 | K221921 | DTX Studio Clinic 3.0 Nobel Biocare AB, SE | MYN |
| Mar 25, 2022 | K213562 | DTX Studio Clinic 3.0 Nobel Biocare AB, SE | LLZ |
| Sep 24, 2021 | K212125 | Nobel Biocare Dental Implant Systems Portfolio - MR Conditional Nobel Biocare AG, CH | DZE |
| Dec 3, 2020 | K202452 | NobelProcera Zirconia Implant Bridge Nobel Biocare AB, SE | NHA |
| Nov 20, 2020 | K203156 | DTX Studio Clinic Nobel Biocare AB, SE | LLZ |
| Nov 16, 2020 | K202344 | TiUltra Implants and Xeal Abutments Nobel Biocare AB, SE | DZE |
| Oct 8, 2020 | K200810 | IPS CaseDesigner Nobel Biocare AB, SE | LLZ |
| Mar 30, 2020 | K200040 | Universal Base Conical Connection (CC) Nobel Biocare AG, CH | NHA |
| Aug 29, 2019 | K191475 | Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate Nobel Biocare AB, SE | KCT |
| Mar 1, 2019 | K181932 | DTX Studio design Nobel Biocare AB, SE | PNP |
| Feb 21, 2019 | K173418 | NobelParallel Conical Connection Nobel Biocare AB, SE | DZE |
| Dec 12, 2018 | K181869 | On1 Universal Abutment Nobel Biocare AB, SE | NHA |
| Dec 4, 2018 | K183069 | NobelZygoma 0° Nobel Biocare AB, SE | DZE |
| Oct 31, 2018 | K180899 | Universal Base Abutment Nobel Biocare AB, SE | NHA |
| Sep 27, 2018 | K181075 | PureSet Tray Nobel Biocare AB, SE | KCT |
| Jan 22, 2018 | K163600 | Kit Boxes and Kit Plates Nobel Biocare AB, SE | KCT |
| Jan 11, 2018 | K172224 | DTX Studio diagnose Nobel Biocare AB, SE | LLZ |
| Dec 14, 2017 | K172854 | NobelPerfect Abutments Nobel Biocare AB, SE | NHA |
| Nov 29, 2017 | K171466 | NobelDesign, DTX Studio Design Nobel Biocare AB, SE | NHA |
| Oct 26, 2017 | K171142 | Healing Cap Multi-Unit Titanium Nobel Biocare AB, SE | NHA |
| Oct 20, 2017 | K172352 | TREFOIL System Nobel Biocare AB, SE | DZE |
| May 11, 2017 | K170135 | TREFOIL System Nobel Biocare AB, SE | DZE |
| Mar 16, 2017 | K161416 | Multi-unit Abutment Plus Nobel Biocare AB, SE | NHA |
| Mar 14, 2017 | K161598 | NobelZygoma 0° Nobel Biocare AB, SE | DZE |
| Feb 28, 2017 | K161655 | On1 Concept Nobel Biocare AB, SE | NHA |
| Jan 31, 2017 | K163122 | NobelClinician, DTX Studio implant Nobel Biocare AB, SE | LLZ |
| Nov 22, 2016 | K162043 | NobelProcera HT ML FCZ Bridge Nobel Biocare AB, SE | ELL |
| Nov 22, 2016 | K161435 | Temporary Snap Abutment Nobel Biocare AB, SE | NHA |
| Nov 10, 2016 | K161634 | IPS CaseDesigner Nobel Biocare AB, SE | LLZ |
| Jul 25, 2016 | K160158 | NobelProcera HT ML FCZ Implant Bridge and Framework Nobel Biocare AB, SE | NHA |
| Jun 6, 2016 | K153534 | NobelProcera HT ML Full Contour Zirconia Crown Nobel Biocare AB, SE | ELL |
| Jun 2, 2016 | K160119 | NobelSpeedy Groovy Nobel Biocare AB, SE | DZE |
| Jun 2, 2016 | K153036 | NobelDesign Software Nobel Biocare AB, SE | NHA |
| Apr 11, 2016 | K152836 | TREFOIL System Nobel Biocare AB, SE | DZE |
| Mar 16, 2016 | K152093 | NobelZygoma 45° Nobel Biocare AB, SE | DZE |
| May 11, 2015 | K142260 | NobelActive Nobel Biocare AB, SE | DZE |
| Jul 24, 2014 | K132749 | NOBELPROCERA OVERDENTURE BAR Nobel Biocare USA, LLC | NHA |
| May 8, 2014 | K133731 | NOBELACTIVE WIDE PLATFORM (WP) Nobel Biocare AB | DZE |
| Apr 4, 2014 | K133377 | NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT REPLACE Nobel Biocare AB | NHA |
| Jan 30, 2014 | K132746 | NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT CONICAL CONNECTION Nobel Biocare USA, LLC | NHA |
| Jun 5, 2013 | K120954 | NOBELPROCERA PEEK ABUTMENTS Nobel Biocare AB | NHA |
| Mar 26, 2013 | K123976 | NOBELCLINICIAN Nobel Biocare AB | LLZ |
Newest 50 of 105.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 5, 2025 | Nobel Biocare . Nobel Biocare N1 TiUltra TCC RP 4.0x9mm
. Nobel Biocare N1 TiUltra TCC RP 4.0x11mm
. Nobel Biocare N1 TiUltra TCC RP 4.0x13mm
Nobel Biocare N1 TiUltra TCC implants are intended for use as an endoss Open, Classified |
DZE | K211109 |
| Aug 23, 2022 | Nobel Biocare Nobel Biocare N1 TiUltra TCC NP 3.5x13mm Open, Classified |
DZE | K211109 |
| Dec 17, 2021 | Nobel Biocare Usa Llc NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R Terminated |
DZE | K073142 |
| May 4, 2020 | Nobel Biocare Usa Llc NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); REF 37965; UDI
(01)07332747091441(10)12129104(17)240203 - Product Usage: are intended to be used in the upper or lower jaw b Terminated |
DZE | K173418 |
| Feb 19, 2020 | Nobel Biocare Usa Llc Abutment Screw Retrieval Instrument RP/WP/6.0 - Product Usage: The instruments for abutment screw retrieval can be used if an abutment screw is broken and a part of the screw is left inside the implan Terminated |
NDP | None listed |
| Feb 19, 2020 | Nobel Biocare Usa Llc Abutment Screw Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but included devices have specific intended use as shown above. Terminated |
DZE | K955697 |
| Feb 19, 2020 | Nobel Biocare Usa Llc Implant Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but included devices have specific intended use as shown above. Terminated |
DZI | K990846 |
| Feb 19, 2020 | Nobel Biocare Usa Llc Abutment Screw Retrieval Instrument 3.0/NP - Product Usage: The instruments for abutment screw retrieval can be used if an abutment screw is broken and a part of the screw is left inside the implant s Terminated |
NDP | None listed |
| Feb 19, 2020 | Nobel Biocare Usa Llc Implant Retrieval Instrument Tri Channel 6.0 22 mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal con Terminated |
NDP | None listed |
| Feb 19, 2020 | Nobel Biocare Usa Llc Implant Retrieval Instrument CC RP & Tri Ch Hex WP 22 mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with inter Terminated |
NDP | None listed |
| Feb 19, 2020 | Nobel Biocare Usa Llc Implant Retrieval Instrument CC NP & Ext Hex WP 22 mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal Terminated |
NDP | None listed |
| Feb 19, 2020 | Nobel Biocare Usa Llc Implant Retrieval Instrument CC 3.0 31 mm- Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal conical conne Terminated |
NDP | None listed |
| Feb 19, 2020 | Nobel Biocare Usa Llc Implant Retrieval Instrument Hex & Tri-Chi NP/RP 31mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal Terminated |
NDP | None listed |
| Feb 19, 2020 | Nobel Biocare Usa Llc Implant Retrieval Instrument Hex & Tri-Ch NP/RP 22mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal c Terminated |
NDP | None listed |
| Feb 19, 2020 | Nobel Biocare Usa Llc Dense Bone Drill WP 5x13 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement. Terminated |
DZI | K990846 |
| Feb 19, 2020 | Nobel Biocare Usa Llc Dense Bone Drill NP 3.5x16 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement. Terminated |
DZI | K990846 |
| Feb 19, 2020 | Nobel Biocare Usa Llc Drill Tapered 6.0 6x8 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement. Terminated |
DZI | K990846 |
| Feb 19, 2020 | Nobel Biocare Usa Llc Drill Tapered WP 5x11.5 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement. Terminated |
DZI | K990846 |
| Feb 19, 2020 | Nobel Biocare Usa Llc Drill Tapered WP 5x10 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement. Terminated |
DZI | K990846 |
| Feb 19, 2020 | Nobel Biocare Usa Llc Drill Tapered RP 4.3x13 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants. Terminated |
DZI | K990846 |
| Feb 19, 2020 | Nobel Biocare Usa Llc Drill Tapered RP 4.3x11.5 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants. Terminated |
DZI | K990846 |
| Feb 19, 2020 | Nobel Biocare Usa Llc Drill Tapered RP 4.3x10 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants. Terminated |
DZI | K990846 |
| Feb 19, 2020 | Nobel Biocare Usa Llc Drill Tapered NP 3.5x11.5 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants. Terminated |
DZI | K990846 |
| Feb 19, 2020 | Nobel Biocare Usa Llc Drill Tapered NP 3.5x10 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants. Terminated |
DZI | K990846 |
| Feb 19, 2020 | Nobel Biocare Usa Llc Screw Tap Tapered WP Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants. Terminated |
DZI | K990846 |
| Feb 19, 2020 | Nobel Biocare Usa Llc Dense Bone Drill 6.0 6x16 mm Single-Pat- Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants. Terminated |
DZI | K990846 |
| Feb 19, 2020 | Nobel Biocare Usa Llc Drill Tapered NP 3.5x8 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants. Terminated |
DZI | K990846 |
| Feb 19, 2020 | Nobel Biocare Usa Llc Guided Start Drills/Counterbore NobRpl NP - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants Terminated |
DZE | K030685 |
| Aug 9, 2019 | Nobel Biocare Usa Llc Temporary Snap Abutment Engaging CC RP 1.5 mm; Pre-manufactured prosthetic components directly connected to the endosseous implant; catalog no. 38761 - Product Usage: Dental implant abutments are inte Terminated |
NHA | K161435 |
| Aug 9, 2019 | Nobel Biocare Usa Llc Universal Base CC RP 1.5 mm; The Universal Base Abutment in combination with Nobel Biocare end osseous implants are indicated for single-unit if screw retained and for multiple-unit if cement retained Terminated |
DZE | K925762 |
| Aug 9, 2019 | Nobel Biocare Usa Llc Snappy Abutment 5.5 CC RP 3 mm; pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36683 - - Product Usage: Dental implant abutments are intended to be us Terminated |
NHA | K071370 |
| Aug 9, 2019 | Nobel Biocare Usa Llc Esthetic Abutment CC RP 1.5 mm pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36669 - Product Usage: Dental implant abutments are intended to be used Terminated |
NHA | K071370 |
| Aug 9, 2019 | Nobel Biocare Usa Llc Temporary Abutment Engaging CC RP pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36664 - - Product Usage: Dental implant abutments are intended to be Terminated |
NHA | K974150 |
| Aug 9, 2019 | Nobel Biocare Usa Llc Temporary Abutment Non-Engaging CC RP pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36662 - Product Usage: Dental implant abutments are intended to b Terminated |
NHA | K974150 |
| Jul 19, 2019 | Nobel Biocare Usa Llc NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI: (01)07332747010619 Terminated |
NHA | K071370 |
| May 28, 2019 | Nobel Biocare Usa Llc Healing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747034462 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting Terminated |
DZE | K071370 |
| Jul 23, 2018 | Nobel Biocare Usa Llc Nobel Biocare 17 Multi-Unit Abutment, Conical Connection NP, 2.5mm, REF 36614.
Product Usage:
Intended to be used in the upper and lower jaw and used for supporting tooth replacements to restore che Terminated |
NHA | K072570 |
| Jul 20, 2016 | Nobel Biocare Usa Llc Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit
Instructions for Use (IFU): "NobelGuide for NobelParallel Conical Connection", id # 2002 and Manual: Guided Surgery with NobelParall Terminated |
DZI | K990846 |
| Jun 22, 2016 | Nobel Biocare Usa Llc Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105
Replace Select Tapered implants are root-form endosseous implants intended to be surgically placed in the bone of the upper and lower jaw ar Terminated |
DZE | None listed |
| Jul 15, 2015 | Nobel Biocare Usa Llc Abutment Retrieval Instrument Zirconia CC RP/WP, Article No. 37882 and Abutment Retrieval Kit, Article No. 37508 (Article No. 37882 was assembled in this kit). Used to remove a zirconia abutment if t Terminated |
NDP | None listed |
| Apr 13, 2015 | Nobel Biocare Usa Llc NobelReplace CC PMC RP 5.0x13mm, Article No. 37298. Terminated |
DZE | K023113 K050258 +1 |
| Apr 13, 2015 | Nobel Biocare Usa Llc NobelReplace CC PMC RP 5.0x10mm, Article No. 37296. Terminated |
DZE | K023113 K050258 +1 |
| Apr 13, 2015 | Nobel Biocare Usa Llc NobelReplace CC PMC RP 4.3x10mm, Article No. 37291. Terminated |
DZE | K023113 K050258 +1 |
| Apr 13, 2015 | Nobel Biocare Usa Llc NobelReplace CC PMC RP 4.3x8mm, Article No. 37290. Terminated |
DZE | K023113 K050258 +1 |
| Apr 13, 2015 | Nobel Biocare Usa Llc NobelReplace CC PMC NP 3.5x13mm, Article No. 37288. Terminated |
DZE | K023113 K050258 +1 |
| Apr 13, 2015 | Nobel Biocare Usa Llc NobelReplace CC PMC NP 3.5x11.5mm, Article No. 37287. Terminated |
DZE | K023113 K050258 +1 |
| Apr 13, 2015 | Nobel Biocare Usa Llc NobelReplace CC RP 5.0x13mm, Article No. 36713. Terminated |
DZE | K023113 K050258 +1 |
| Apr 13, 2015 | Nobel Biocare Usa Llc NobelReplace CC RP 5.0x10mm, Article No. 36711. Terminated |
DZE | K023113 K050258 +1 |
| Apr 13, 2015 | Nobel Biocare Usa Llc NobelReplace CC RP 5.0x8mm, Article No. 36710. Terminated |
DZE | K023113 K050258 +1 |
| Apr 13, 2015 | Nobel Biocare Usa Llc NobelReplace CC RP 4.3x13mm, Article No. 36708. Terminated |
DZE | K023113 K050258 +1 |
Newest 50 of 70.