Regulatory
Nobel Biocare regulatory records (FDA 510(k))
Public regulatory records are the most reliable facts about a medical device. Here are all FDA 510(k) records we found for Nobel Biocare implants and abutments.
What a 510(k) means
A 510(k) clearance means FDA found a device "substantially equivalent" to one already legally on the US market. It is not a quality ranking, and not a clinical trial result.1
Different regions have different systems. In the EU, devices carry CE marking under the Medical Device Regulation; we focus on FDA because its records are public and searchable.
Implant 510(k)s
| 510(k) | Decision | Device name (as filed) |
|---|---|---|
| K252197 | 18 Feb 2026 | Nobel Biocare S Series Implants |
| K243834 | 25 Aug 2025 | NobelZygoma TiUltra Implant system |
| K211109 | 21 Dec 2021 | N1 TiUltra TCC Implant System |
| K212125 | 24 Sep 2021 | Nobel Biocare Dental Implant Systems Portfolio - MR Conditional |
| K202344 | 16 Nov 2020 | TiUltra Implants and Xeal Abutments |
| K173418 | 21 Feb 2019 | NobelParallel Conical Connection |
| K183069 | 4 Dec 2018 | NobelZygoma 0° |
| K172352 | 20 Oct 2017 | TREFOIL System |
| K170135 | 11 May 2017 | TREFOIL System |
| K161598 | 14 Mar 2017 | NobelZygoma 0° |
| K160119 | 2 Jun 2016 | NobelSpeedy Groovy |
| K152836 | 11 Apr 2016 | TREFOIL System |
| K152093 | 16 Mar 2016 | NobelZygoma 45° |
| K142260 | 11 May 2015 | NobelActive |
| K133731 | 8 May 2014 | NOBELACTIVE WIDE PLATFORM (WP) |
| K102436 | 9 Dec 2010 | NOBEL ACTIVE 3.0 |
| K083205 | 13 Feb 2009 | NOBELACTIVE 8.5 MM & 18.0 MM |
| K081128 | 7 Nov 2008 | MOLAR IMPLANT |
| K073142 | 11 Jan 2008 | NOBELREPLACE HEXAGONAL IMPLANT |
| K070857 | 28 Dec 2007 | NOBELDIRECT 3.0-IMMEDIATE LOAD, 3.0 X 13 MM AND 3.0 X 15 MM |
| K072980 | 20 Dec 2007 | NOBELPERFECT CONICAL CONNECTION HEXAGONAL IMPLANTS |
| K071370 | 3 Aug 2007 | NOBELACTIVE INTERNAL CONNECTION IMPLANT |
| K070182 | 4 Apr 2007 | ZYGOMA IMPLANT (IMMEDIATE FUNCTION) |
| K061971 | 6 Mar 2007 | ZIRCONIA IMPLANT |
| K063718 | 5 Jan 2007 | SFB AND CFB IMPLANTS - 5.0 PLATFORM |
| K062936 | 19 Dec 2006 | NOBELPERFECT CONICAL CONNECTION |
| K062566 | 6 Dec 2006 | NOBELREPLACE TAPERED CONICAL CONNECTION |
| K061003 | 30 Jun 2006 | SFB & CFB IMPLANTS |
| K050406 | 8 Jun 2005 | NOBELSPEEDY IMPLANTS |
| K050705 | 19 May 2005 | TIUNITE IMPLANTS |
| K050393 | 4 May 2005 | THE GUIDED SURGERY CONCEPT |
| K050258 | 19 Apr 2005 | GROOVY IMPLANTS |
| K041661 | 26 Aug 2004 | NOBEL BIOCARE ENDOSSEOUS IMPLANTS |
| K041876 | 20 Aug 2004 | NOBELDIRECT OD IMPLANT |
| K030685 | 6 Feb 2004 | TEETH IN AN HOUR - ARK IMPLANT CONCEPT |
| K031345 | 24 Jul 2003 | NOBEL DIRECT, MODELS 30937, 30938 |
| K030257 | 10 Feb 2003 | NOBEL PERFECT IMPLANT SYSTEM |
| K023952 | 16 Jan 2003 | REPLACE ONE PIECE IMPLANT, HA, REPLACE ONE PIECE IMPLANT, TIUNITE |
| K022562 | 11 Oct 2002 | VARIOUS BRANEMARK SYSTEM IMPLANTS-IMMEDIATE FUNCTION INDICATION |
| K022424 | 27 Sep 2002 | REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132 & 60162 |
| K023113 | 26 Sep 2002 | REPLACE TIUNITE ENDOSSEOUS IMPLANT |
| K021584 | 5 Jun 2002 | REPLACE SCALLOPED MARGIN IMPLANT SYSTEM |
| K020646 | 29 May 2002 | REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132, & 60162 |
| K002475 | 9 Nov 2000 | REPLACE TPS COATED IMPLANTS |
| K000643 | 7 Sep 2000 | INPLANT ORTHODONTIC ANCHOR SYSTEM |
| K000018 | 30 Mar 2000 | BRANEMARK NOVUM |
| K992937 | 29 Feb 2000 | DENTAL IMPLANT |
| K993595 | 28 Jan 2000 | NOBEL BIOCARE'S MODIFIED SURFACE IMPLANT (INTENDED FOR IMMEDIATE LOADING UPON PLACEMENT) |
| K992538 | 23 Nov 1999 | AMORPHOUS DIAMOND COATED SCREW |
| K984287 | 1 Mar 1999 | PROVISIONAL DENTAL IMPLANT SYSTEM |
| K974123 | 26 May 1998 | BRANEMARK SYSTEM DEC 600 DRILLING UNIT |
| K980460 | 5 May 1998 | ONPLANT ORTHODONTIC SYSTEM |
| K974828 | 24 Mar 1998 | BRANEMARK SYSTEM(R) EBON(TM) FIXTURE |
| K970499 | 16 Oct 1997 | BRANEMARK SYSTEM ZYGOMATICUS FIXTURE SYSTEM |
54 record(s) from the openFDA 510(k) database, retrieved 28 Sep 2026. A 510(k) clearance means FDA found a device substantially equivalent to one already on the market; it is not a quality ranking.
Abutment and prosthetic 510(k)s
| 510(k) | Decision | Device name (as filed) |
|---|---|---|
| K253999 | 6 Aug 2026 | Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic Screw |
| K240346 | 3 Jan 2025 | NobelProcera Zirconia Implant Bridge |
| K233208 | 24 Jan 2024 | NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium |
| K223677 | 28 Apr 2023 | Titanium Abutment Blank Nobel Biocare N1 TCC |
| K220339 | 16 Sep 2022 | Esthetic Abutments Nobel Biocare N1 |
| K220048 | 29 Jul 2022 | NobelProcera Zirconia N1 Base |
| K202452 | 3 Dec 2020 | NobelProcera Zirconia Implant Bridge |
| K200040 | 30 Mar 2020 | Universal Base Conical Connection (CC) |
| K181869 | 12 Dec 2018 | On1 Universal Abutment |
| K180899 | 31 Oct 2018 | Universal Base Abutment |
| K172854 | 14 Dec 2017 | NobelPerfect Abutments |
| K171466 | 29 Nov 2017 | NobelDesign, DTX Studio Design |
| K171142 | 26 Oct 2017 | Healing Cap Multi-Unit Titanium |
| K161416 | 16 Mar 2017 | Multi-unit Abutment Plus |
| K161655 | 28 Feb 2017 | On1 Concept |
| K161435 | 22 Nov 2016 | Temporary Snap Abutment |
| K160158 | 25 Jul 2016 | NobelProcera HT ML FCZ Implant Bridge and Framework |
| K153036 | 2 Jun 2016 | NobelDesign Software |
| K132749 | 24 Jul 2014 | NOBELPROCERA OVERDENTURE BAR |
| K133377 | 4 Apr 2014 | NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT REPLACE |
| K132746 | 30 Jan 2014 | NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT CONICAL CONNECTION |
| K120954 | 5 Jun 2013 | NOBELPROCERA PEEK ABUTMENTS |
| K122602 | 13 Mar 2013 | NOBELPROCERA TI ABUTMENT CAMLOG PLATFORMS |
| K112259 | 28 Oct 2011 | NOBELACTIVE 3.0 GOLDADAPT ABUTMENTS |
| K111581 | 23 Jun 2011 | 15 ESTHETIC ABUTMENT NOBELACTIVE 03.0 1.5MM, 15 ESTHETIC ABUTMENT NOBELACTIVE 03.0 3MM, 15 ESTHETIC ABUTMENT NOBELACTIVE |
| K110171 | 15 Jun 2011 | NOBELPROCERA ZI ABUTMENT THOMMEN PLATFORMS |
| K101714 | 31 Aug 2010 | NOBELPROCERA TI ABUTMENT THOMMEN PLATFORMS |
| K093643 | 24 Jun 2010 | MULTI- UNIT ABUTMENTS FOR STRAUMANN AND ASTRA TECH IMPLANT SYSTEMS |
| K091848 | 16 Oct 2009 | NOBEL/PROCERA IMPLANT BRIDGE |
| K091907 | 6 Oct 2009 | NOBELPROCERA IMPLANT BRIDGE ZIRCONIA |
| K091904 | 25 Sep 2009 | NOBELPROCERA ZI ABUTMENT |
| K091756 | 22 Sep 2009 | NOBELPROCERA TI ABUTMENT |
| K090069 | 7 May 2009 | PROCERA IMPLANT BRIDGE OVERDENTURE |
| K083100 | 19 Nov 2008 | GOLDADAPT NON-ENGAGING NOBELACTIVE NP & RP, GOLDADAPT ENGAGING NOBELACTIVE NP & RP |
| K072129 | 22 Feb 2008 | NOBELACTIVE ZIRCONIA ABUTMENT |
| K072570 | 28 Dec 2007 | NOBELACTIVE MULTI UNIT ABUTMENT |
| K063592 | 27 Feb 2007 | ADAPTER PS RP-NP, 34551, ADAPTER PS WP-RP,34552, ABUTMENT SCREW PS RP-NP, 34553, ABUTMENT SCREW PS WP-RP, 34554 |
| K062749 | 29 Nov 2006 | SBF 15 ESTHETIC ABUTMENT 1MM NP, MODEL 33699, SFB 15 ESTHETIC ABUTMENT 1MM RP, MODEL 33701, CFB 15 ESTHETIC ABUTMENT 2MM |
| K061529 | 23 Aug 2006 | PROCERA ZIRCONIA ABUTMENT FOR CAMLOG IMPLANT SYSTEM |
| K061478 | 21 Aug 2006 | PROCERA TITANIUM ABUTMENT FOR ASTRATECH AND CAMLOG IMPLANT SYSTEMS |
| K061477 | 11 Aug 2006 | MULTI-UNIT ABUTMENTS FOR ASTRATECH, CAMLOG AND ANKYLOS IMPLANT SYSTEMS |
| K053068 | 22 Feb 2006 | PROCERA BRIDGE LAMINATE, MODEL 40-4002 |
| K053050 | 22 Feb 2006 | PROCERA BRIDGE ALUMINA |
| K053125 | 22 Feb 2006 | PROCERA BRIDGE ZIRCONIA |
| K053602 | 10 Feb 2006 | PROCERA SOFTWARE, MODEL 33145 |
| K053091 | 27 Jan 2006 | PROCERA IMPLANT BRIDGE ZIRCONIA |
| K052885 | 23 Dec 2005 | ZYGOMA 17 ABUTMENT MULTI-UNIT RP 2MM, MODEL 29314; ZYGOMA 17 ABUTMENT MULTI-UNIT RP 3MM, MODEL 29315 |
| K050444 | 7 Jul 2005 | NOBELREPLACE ADAPTER, MODEL 32412 |
| K050641 | 7 Apr 2005 | ZYGOMA TIUNITE |
| K043042 | 18 Nov 2004 | PROCERA IMPLANT BRIDGE, MODELS 15-1001, 15-1002, 15-1051, 15-1052 |
| K042658 | 20 Oct 2004 | PROCERA ABUTMENT BRANEMARK, MODELS 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004 |
| K041275 | 27 May 2004 | PROCERA ABUTMENT OCTAGON |
| K041236 | 26 May 2004 | PROCERA IMPLANT BRIDGE, MODELS 15-1001, 15-1002, 15-1051, 15-1052 |
| K040573 | 28 Apr 2004 | NOBEL BIOCARE PERMANENT CENTRIC POST, MODELS 31234, 31235, 31236 |
| K033724 | 23 Feb 2004 | NOBEL BIOCARE CENTRIC POST, MODELS 31234, 31235 AND 31236 |
| K031719 | 2 Jul 2003 | ESTHETIC ZIRCONIA ABUTMENT |
| K974150 | 23 Jan 1998 | PROCERA PREPARABLE ABUTMENT SYSTEM |
| K972475 | 12 Sep 1997 | AURADAPT AUBTMENT SYSTEM |
| K971706 | 21 Jul 1997 | TIADAPT ABUTMENT SYSTEM |
59 record(s) from the openFDA 510(k) database, retrieved 28 Sep 2026. A 510(k) clearance means FDA found a device substantially equivalent to one already on the market; it is not a quality ranking.
Last updated 28 Sep 2026.
Sources
- Regulatory recordPremarket Notification 510(k) — what a 510(k) clearance means — U.S. Food and Drug Administration, 2026-09-28. Accessed 28 Sep 2026.
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