Implant, Endosseous, Root-Form
Regulation 872.3640
20510(k)s in 12 months (1,550 all time)
2recalls in 12 months (212 all time)
192recalls that name a 510(k)
Top companies in DZE
| Company | 510(k)s | Recalls |
|---|---|---|
| Nobel Biocare AB | 33 | 37 |
| Biomet 3i | 11 | 52 |
| Nobelpharma AB | 52 | 0 |
| Zimmer Dental, Inc. | 19 | 30 |
| Straumann USA | 35 | 9 |
| Implant Innovations, Inc. | 37 | 4 |
| Steri-Oss, Inc. | 40 | 0 |
| BioHorizons Implant Systems, Inc. | 26 | 12 |
| Minimatic Implant Technology | 34 | 0 |
| Implant Center of the Palm Beaches | 32 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 15, 2026 | Straumann USA LLC GM Helix Implant, REF: 109.984; Open, Classified |
DZE | K163194 |
| Aug 11, 2026 | Straumann USA LLC Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endosseous, root-form Open, Classified |
DZE | K140878 |
| Oct 1, 2025 | S.I.N. Implant System Ltda IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N;
IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N;
IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF: ILM 3513N;
IMPLANT EPIKUT PLUS MT16 3,5X15,0MM, RE Open, Classified |
DZE | None listed |
| May 28, 2025 | Straumann USA LLC GM Helix Acqua Implant, Article Number: 140.985 Open, Classified |
DZE | K163194 |
| May 28, 2025 | Straumann USA LLC GM Helix Acqua Implant, Article Number: 140.984 Open, Classified |
DZE | K163194 |
| 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 |
| Jan 15, 2025 | SIN SISTEMA DE IMPLANTE NACIONAL S.A Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N Open, Classified |
DZE | K222231 |
| May 18, 2023 | Hiossen Inc. ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended for Dental Implant
Catalog #: AET3R5010B Open, Classified |
DZE | K151626 |
| 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 |
| Nov 30, 2021 | Straumann USA LLC Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5
Article Number: 138.107 Terminated |
DZE | K203382 |
| Nov 30, 2021 | Straumann USA LLC Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant
Item 138.089 Terminated |
DZE | K203382 |
| Oct 11, 2021 | Jjgc Industria E Comercio De Materials Dentarios Sa GM Helix Acqua Implant 3.5x10, Article No. 140.944 Terminated |
DZE | K163194 |
| Sep 23, 2021 | Implant Direct Sybron Manufacturing LLC ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform, Open, Classified |
DZE | K192221 |
| Sep 23, 2021 | Implant Direct Sybron Manufacturing LLC ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform, Open, Classified |
DZE | K192221 |
| Jul 20, 2020 | NOBEL BIOCARE SERVICES AG NobelReplace Conical Connection (CC) PMC RP 4.3x10mm, REF: 37291 - Product Usage: implants are intended to be used in the upper or lower jaw bone (osseointegration) and used for anchoring or supportin 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 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 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 |
| Feb 5, 2020 | Implant Direct Sybron Manufacturing LLC Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7mmD Platform, RxOnly, Sterile R, Terminated |
DZE | K090234 |
| Feb 4, 2020 | Implant Direct Sybron Manufacturing LLC Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213 Terminated |
DZE | K090234 |
| Nov 22, 2019 | Zest Anchors LLC LOCATOR OVERDENTURE IMPLANT SYSTEM STERILE R Rx Only QTY 1 . Open, Classified |
DZE | K120198 |
| Nov 18, 2019 | Paltop Advanced Dental Solutions Ltd Paltop Dynamic Dental Implant Dia 3.25mm L 13.0 mm, Catalog Number 21-70020 Terminated |
DZE | K130462 |
| Nov 12, 2019 | Implant Direct Sybron Manufacturing, LLC Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA
Dental Implants Terminated |
DZE | K090234 |
| 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 |
| May 30, 2019 | Paltop Advanced Dental Solutions Ltd Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm
Catalog Number: 20-70024P Terminated |
DZE | K112795 |
| 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 |
| Feb 22, 2019 | Keystone Dental Inc Paltop 1.25 Hex Drivers, Short
Part Number: 60-70102 Terminated |
DZE | K112795 |
| Feb 22, 2019 | Keystone Dental Inc Paltop 1.25 Hex Drivers, Long
Part Number: 60-70101 Terminated |
DZE | K112795 |
| Feb 22, 2019 | Keystone Dental Inc Paltop Fully Guided Surgical Kit- containing the 1.25mm Hex Driver
For surgical and restorative applications prosthetic devices, such as artificial teeth
Part Number: 30-70021 Terminated |
DZE | K112795 |
| Feb 22, 2019 | Keystone Dental Inc Paltop Premium Surgical Kit-containing the 1.25mm Hex Driver
For surgical and restorative applications prosthetic devices, such as artificial teeth
Part Number: 60-70112 Terminated |
DZE | K112795 |
| Oct 26, 2018 | Implant Direct Sybron Manufacturing, LLC Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R
Dental Implant Terminated |
DZE | K130572 |
| Oct 2, 2018 | Straumann Manufacturing, Inc. Neodent GM Mini Conical Abutment - Product Usage: Mini Conical Abutments are intermediary prosthetic components to be installed onto GM implants to support the final prosthesis. They are provided in a Terminated |
DZE | K163194 |
| Aug 8, 2018 | Implant Direct Sybron Manufacturing, LLC ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216.
The responsible firm on the Terminated |
DZE | K090234 |
| Aug 7, 2018 | Implant Direct Sybron Manufacturing, LLC ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. Terminated |
DZE | K061319 |
| May 18, 2018 | Implant Direct Sybron Manufacturing, LLC REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60 Terminated |
DZE | K061319 |
| May 10, 2018 | Zimmer Dental Inc Outer Package Label: Tapered Screw-Vent Implant System, 4.1mm X 10mm, 3.5mm, REF:TSVM4B10, Sterile:R, Rx Only; Inner Package Label: Implant, MTX, 3.7mm x 10mm,3.5mm, REF: TSVB10.
Zimmer Dental Impl Terminated |
DZE | K111889 |
| May 1, 2018 | Keystone Dental Inc Prima Plus 4.1 x 11.5mm Implant, Catalog Number 15737K
Keystone Dental implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit res Terminated |
DZE | K051614 |
| Mar 14, 2018 | Implant Direct Sybron Manufacturing, LLC ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platform, Part #655010U, Rx, Sterile. Incorrect label on the cap says 4.3mmD Platform 604313U 13mmL.
Product Usage: Usage:
Den Terminated |
DZE | K130572 |
| Mar 13, 2018 | Keystone Dental Inc Genesis Surgical Cassette Tapered
Implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket Terminated |
DZE | K101545 |
| Mar 5, 2018 | Zimmer Dental Inc Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSV4B10. Terminated |
DZE | K072589 |
| Mar 5, 2018 | Zimmer Dental Inc Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSVTB10. Terminated |
DZE | K101977 |
| Jan 19, 2018 | Implant Direct Sybron Manufacturing, LLC SwishTapered Implant
Intended for use in support for fixed bridgework. Terminated |
DZE | K090234 |
| Nov 20, 2017 | Zimmer Dental Inc Tapered Screw-Vent MTX Model TSVTB11 Terminated |
DZE | K101977 |
| Oct 16, 2017 | Keystone Dental Inc STAGE-1 RDS COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit; Catalog Number: S2437-01-1K Terminated |
DZE | K072768 |
| Oct 10, 2017 | Implant Direct Sybron Manufacturing, LLC ImplantDirect Legacy(TM) 3 Implant, 13MM L, REF 864713
This Legacy implant is a two-piece implant for one-stage or two-stage surgical procedures. These implants are intended for use in partially and Terminated |
DZE | K090234 |
| Aug 25, 2017 | Keystone Dental Inc Stage-1 RDS Indexed Abutment for RDS Stage-1 Single Stage
Implants
Keystone s implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multip Terminated |
DZE | K072768 |
| Jul 10, 2017 | Zimmer Dental Inc IMPLANT,1-PC,ANG,3.0X10MM, REF ZOP30A10;
IMPLANT, 1-PC, ANG, 3.0X11.5MM, REF ZOP30A11;
IMPLANT, 1 -PC,ANG,3.0X13MM, REF ZOP30A13;
IMPLANT 1-PC STR 3.0X10, REF ZOP30S10;
IMPLANT, 1-PC,STR,3 Terminated |
DZE | K052997 K071235 |
| Jul 10, 2017 | Zimmer Dental Inc ABUT GOLD FRICTION-FIT, REF HLA3G;
ABUT GOLD FRICTION-FIT, REF HLA4G;
COPING GOLD ENG 5.7 MM, REF HLA5G;
COPING GOLD NON-ENG. 3.5, REF NEA3G;
COPING GOLD NON-ENG. 4.5, REF NEA4G Terminated |
DZE | K011028 K013227 |
| Jun 16, 2017 | Keystone Dental Inc Max Implant System - Bone Tap for use with 7.0mm diameter Max Implant, Catalog Number D-TAP-MAX7-7
Dental implants are intended for use as anchors of fixed or semi-fixed dental crowns, bridges, and Terminated |
DZE | K071161 |
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