ClearanceBrief
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

CodeDeviceRecords
DZEImplant, Endosseous, Root-Form70
NHAAbutment, Implant, Dental, Endosseous56
DZIDrill, Bone, Powered15
NDPAccessories, Implant, Dental, Endosseous9
LLZSystem, Image Processing, Radiological8
ELLTeeth, Porcelain5
KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories4
EIHPowder, Porcelain2
EBIResin, Denture, Relining, Repairing, Rebasing1
EBWController, Foot, Handpiece And Cord1
FZEProsthesis, Nose, Internal1
MYNAnalyzer, Medical Image1
PNPDental Abutment Design Software For Dental Laboratory1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Sep 8, 2026K253988LiteSet Trays
Nobel Biocare AB, SE
KCT
Aug 6, 2026K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and No
Nobel Biocare AB, SE
NHA
Feb 18, 2026K252197Nobel Biocare S Series Implants
Nobel Biocare AB, SE
DZE
Aug 25, 2025K243834NobelZygoma TiUltra Implant system
Nobel Biocare AB, SE
DZE
Jan 3, 2025K240346NobelProcera Zirconia Implant Bridge
Nobel Biocare AB, SE
NHA
Jan 24, 2024K233208NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium
Nobel Biocare AB, SE
NHA
Dec 8, 2023K231898DTX Studio Clinic (4.0)
Nobel Biocare AB, SE
LLZ
Apr 28, 2023K223677Titanium Abutment Blank Nobel Biocare N1 TCC
Nobel Biocare AB, SE
NHA
Mar 28, 2023K221921DTX Studio Clinic 3.0
Nobel Biocare AB, SE
MYN
Mar 25, 2022K213562DTX Studio Clinic 3.0
Nobel Biocare AB, SE
LLZ
Sep 24, 2021K212125Nobel Biocare Dental Implant Systems Portfolio - MR Conditional
Nobel Biocare AG, CH
DZE
Dec 3, 2020K202452NobelProcera Zirconia Implant Bridge
Nobel Biocare AB, SE
NHA
Nov 20, 2020K203156DTX Studio Clinic
Nobel Biocare AB, SE
LLZ
Nov 16, 2020K202344TiUltra Implants and Xeal Abutments
Nobel Biocare AB, SE
DZE
Oct 8, 2020K200810IPS CaseDesigner
Nobel Biocare AB, SE
LLZ
Mar 30, 2020K200040Universal Base Conical Connection (CC)
Nobel Biocare AG, CH
NHA
Aug 29, 2019K191475Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate
Nobel Biocare AB, SE
KCT
Mar 1, 2019K181932DTX Studio design
Nobel Biocare AB, SE
PNP
Feb 21, 2019K173418NobelParallel Conical Connection
Nobel Biocare AB, SE
DZE
Dec 12, 2018K181869On1 Universal Abutment
Nobel Biocare AB, SE
NHA
Dec 4, 2018K183069NobelZygoma 0°
Nobel Biocare AB, SE
DZE
Oct 31, 2018K180899Universal Base Abutment
Nobel Biocare AB, SE
NHA
Sep 27, 2018K181075PureSet Tray
Nobel Biocare AB, SE
KCT
Jan 22, 2018K163600Kit Boxes and Kit Plates
Nobel Biocare AB, SE
KCT
Jan 11, 2018K172224DTX Studio diagnose
Nobel Biocare AB, SE
LLZ
Dec 14, 2017K172854NobelPerfect Abutments
Nobel Biocare AB, SE
NHA
Nov 29, 2017K171466NobelDesign, DTX Studio Design
Nobel Biocare AB, SE
NHA
Oct 26, 2017K171142Healing Cap Multi-Unit Titanium
Nobel Biocare AB, SE
NHA
Oct 20, 2017K172352TREFOIL System
Nobel Biocare AB, SE
DZE
May 11, 2017K170135TREFOIL System
Nobel Biocare AB, SE
DZE
Mar 16, 2017K161416Multi-unit Abutment Plus
Nobel Biocare AB, SE
NHA
Mar 14, 2017K161598NobelZygoma 0°
Nobel Biocare AB, SE
DZE
Feb 28, 2017K161655On1 Concept
Nobel Biocare AB, SE
NHA
Jan 31, 2017K163122NobelClinician, DTX Studio implant
Nobel Biocare AB, SE
LLZ
Nov 22, 2016K162043NobelProcera HT ML FCZ Bridge
Nobel Biocare AB, SE
ELL
Nov 22, 2016K161435Temporary Snap Abutment
Nobel Biocare AB, SE
NHA
Nov 10, 2016K161634IPS CaseDesigner
Nobel Biocare AB, SE
LLZ
Jul 25, 2016K160158NobelProcera HT ML FCZ Implant Bridge and Framework
Nobel Biocare AB, SE
NHA
Jun 6, 2016K153534NobelProcera HT ML Full Contour Zirconia Crown
Nobel Biocare AB, SE
ELL
Jun 2, 2016K160119NobelSpeedy Groovy
Nobel Biocare AB, SE
DZE
Jun 2, 2016K153036NobelDesign Software
Nobel Biocare AB, SE
NHA
Apr 11, 2016K152836TREFOIL System
Nobel Biocare AB, SE
DZE
Mar 16, 2016K152093NobelZygoma 45°
Nobel Biocare AB, SE
DZE
May 11, 2015K142260NobelActive
Nobel Biocare AB, SE
DZE
Jul 24, 2014K132749NOBELPROCERA OVERDENTURE BAR
Nobel Biocare USA, LLC
NHA
May 8, 2014K133731NOBELACTIVE WIDE PLATFORM (WP)
Nobel Biocare AB
DZE
Apr 4, 2014K133377NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT REPLACE
Nobel Biocare AB
NHA
Jan 30, 2014K132746NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT CONICAL CONNECTION
Nobel Biocare USA, LLC
NHA
Jun 5, 2013K120954NOBELPROCERA PEEK ABUTMENTS
Nobel Biocare AB
NHA
Mar 26, 2013K123976NOBELCLINICIAN
Nobel Biocare AB
LLZ

Newest 50 of 105.

Latest recalls

DateFirm and productCodeLinked 510(k)
Feb 5, 2025Nobel 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
DZEK211109
Aug 23, 2022Nobel Biocare
Nobel Biocare N1 TiUltra TCC NP 3.5x13mm
Open, Classified
DZEK211109
Dec 17, 2021Nobel Biocare Usa Llc
NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R
Terminated
DZEK073142
May 4, 2020Nobel 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
DZEK173418
Feb 19, 2020Nobel 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
NDPNone listed
Feb 19, 2020Nobel 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
DZEK955697
Feb 19, 2020Nobel 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
DZIK990846
Feb 19, 2020Nobel 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
NDPNone listed
Feb 19, 2020Nobel 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
NDPNone listed
Feb 19, 2020Nobel 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
NDPNone listed
Feb 19, 2020Nobel 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
NDPNone listed
Feb 19, 2020Nobel 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
NDPNone listed
Feb 19, 2020Nobel 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
NDPNone listed
Feb 19, 2020Nobel 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
NDPNone listed
Feb 19, 2020Nobel 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
DZIK990846
Feb 19, 2020Nobel 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
DZIK990846
Feb 19, 2020Nobel 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
DZIK990846
Feb 19, 2020Nobel 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
DZIK990846
Feb 19, 2020Nobel 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
DZIK990846
Feb 19, 2020Nobel 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
DZIK990846
Feb 19, 2020Nobel 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
DZIK990846
Feb 19, 2020Nobel 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
DZIK990846
Feb 19, 2020Nobel 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
DZIK990846
Feb 19, 2020Nobel 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
DZIK990846
Feb 19, 2020Nobel 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
DZIK990846
Feb 19, 2020Nobel 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
DZIK990846
Feb 19, 2020Nobel 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
DZIK990846
Feb 19, 2020Nobel 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
DZEK030685
Aug 9, 2019Nobel 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
NHAK161435
Aug 9, 2019Nobel 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
DZEK925762
Aug 9, 2019Nobel 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
NHAK071370
Aug 9, 2019Nobel 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
NHAK071370
Aug 9, 2019Nobel 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
NHAK974150
Aug 9, 2019Nobel 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
NHAK974150
Jul 19, 2019Nobel Biocare Usa Llc
NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI: (01)07332747010619
Terminated
NHAK071370
May 28, 2019Nobel 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
DZEK071370
Jul 23, 2018Nobel 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
NHAK072570
Jul 20, 2016Nobel 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
DZIK990846
Jun 22, 2016Nobel 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
DZENone listed
Jul 15, 2015Nobel 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
NDPNone listed
Apr 13, 2015Nobel Biocare Usa Llc
NobelReplace CC PMC RP 5.0x13mm, Article No. 37298.
Terminated
DZEK023113
K050258 +1
Apr 13, 2015Nobel Biocare Usa Llc
NobelReplace CC PMC RP 5.0x10mm, Article No. 37296.
Terminated
DZEK023113
K050258 +1
Apr 13, 2015Nobel Biocare Usa Llc
NobelReplace CC PMC RP 4.3x10mm, Article No. 37291.
Terminated
DZEK023113
K050258 +1
Apr 13, 2015Nobel Biocare Usa Llc
NobelReplace CC PMC RP 4.3x8mm, Article No. 37290.
Terminated
DZEK023113
K050258 +1
Apr 13, 2015Nobel Biocare Usa Llc
NobelReplace CC PMC NP 3.5x13mm, Article No. 37288.
Terminated
DZEK023113
K050258 +1
Apr 13, 2015Nobel Biocare Usa Llc
NobelReplace CC PMC NP 3.5x11.5mm, Article No. 37287.
Terminated
DZEK023113
K050258 +1
Apr 13, 2015Nobel Biocare Usa Llc
NobelReplace CC RP 5.0x13mm, Article No. 36713.
Terminated
DZEK023113
K050258 +1
Apr 13, 2015Nobel Biocare Usa Llc
NobelReplace CC RP 5.0x10mm, Article No. 36711.
Terminated
DZEK023113
K050258 +1
Apr 13, 2015Nobel Biocare Usa Llc
NobelReplace CC RP 5.0x8mm, Article No. 36710.
Terminated
DZEK023113
K050258 +1
Apr 13, 2015Nobel Biocare Usa Llc
NobelReplace CC RP 4.3x13mm, Article No. 36708.
Terminated
DZEK023113
K050258 +1

Newest 50 of 70.

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