Data / Medical devices / Sweden / Nobel Biocare AB
Nobel Biocare AB: FDA-registered device maker in GOTEBORG Vastra Gotaland, Sweden, 84 510(k) clearances
Nobel Biocare AB is registered with the FDA (registration 9611992) in GOTEBORG Vastra Gotaland, Sweden. It lists 15 device types. The FDA files 84 510(k) clearances under its listings, the newest dated September 8, 2026. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9611992
- FEI number
- 3002807692
- Address
- Box 5190, SE-402 26 Vastra Hamngatan 1, GOTEBORG Vastra Gotaland, Sweden, 411 17
- Owner or operator
- Nobel Biocare Services AG (8030879)
- Roles
- Specification developer
- First device listed
- July 8, 2003
- Registered through
- 2027
- Brand names listed
- 1st Generation Surgical Templates, NobelGuide, 2nd Generation Surgical Templates, NobelGuide, Abutment Release Pin, Abutment Replica Multi-unit, Abutment Replica Snappy, Abutment Retrieval Tools/Instruments Titanium, Abutment Retrieval Tools/Instruments Zirconia, Abutment Screw and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 8, 2026 | K253988 | LiteSet Trays | KCT | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| August 6, 2026 | K253999 | 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 | NHA | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| February 18, 2026 | K252197 | Nobel Biocare S Series Implants | DZE | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| November 17, 2025 | K252086 | DTX Studio Assist | MYN | Substantially Equivalent | Nobel Biocare C/O Medicim NV | accessdata.fda.gov |
| August 25, 2025 | K243834 | NobelZygoma TiUltra Implant system | DZE | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| January 3, 2025 | K240346 | NobelProcera Zirconia Implant Bridge | NHA | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| January 24, 2024 | K233208 | NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium | NHA | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| December 8, 2023 | K231898 | DTX Studio Clinic (4.0) | LLZ | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| June 27, 2023 | K231219 | NobelZygoma PureSet Tray | KCT | Substantially Equivalent | Nobel Biocare Services AG | accessdata.fda.gov |
| April 28, 2023 | K223677 | Titanium Abutment Blank Nobel Biocare N1 TCC | NHA | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| March 28, 2023 | K221921 | DTX Studio Clinic 3.0 | MYN | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| September 16, 2022 | K220339 | Esthetic Abutments Nobel Biocare N1 | NHA | Substantially Equivalent | Nobel Biocare Services AG | accessdata.fda.gov |
| July 29, 2022 | K220048 | NobelProcera Zirconia N1 Base | NHA | Substantially Equivalent | Nobel Biocare Services AG | accessdata.fda.gov |
| March 25, 2022 | K213562 | DTX Studio Clinic 3.0 | LLZ | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| December 21, 2021 | K211109 | N1 TiUltra TCC Implant System | DZE | Substantially Equivalent | Nobel Biocare Services AG | accessdata.fda.gov |
| December 18, 2021 | K212932 | Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray | KCT | Substantially Equivalent | Nobel Biocare Services AG | accessdata.fda.gov |
| December 3, 2020 | K202452 | NobelProcera Zirconia Implant Bridge | NHA | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| November 20, 2020 | K203156 | DTX Studio Clinic | LLZ | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| November 16, 2020 | K202344 | TiUltra Implants and Xeal Abutments | DZE | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| October 8, 2020 | K200810 | IPS CaseDesigner | LLZ | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| March 30, 2020 | K200040 | Universal Base Conical Connection (CC) | NHA | Substantially Equivalent | Nobel Biocare AG | accessdata.fda.gov |
| August 29, 2019 | K191475 | Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate | KCT | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| March 1, 2019 | K181932 | DTX Studio design | PNP | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| February 21, 2019 | K173418 | NobelParallel Conical Connection | DZE | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| December 12, 2018 | K181869 | On1 Universal Abutment | NHA | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| September 27, 2018 | K181075 | PureSet Tray | KCT | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| January 11, 2018 | K172224 | DTX Studio diagnose | LLZ | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| December 14, 2017 | K172854 | NobelPerfect Abutments | NHA | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| November 29, 2017 | K171466 | NobelDesign, DTX Studio Design | NHA | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| October 26, 2017 | K171142 | Healing Cap Multi-Unit Titanium | NHA | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| May 11, 2017 | K170135 | TREFOIL System | DZE | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| March 16, 2017 | K161416 | Multi-unit Abutment Plus | NHA | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| March 14, 2017 | K161598 | NobelZygoma 0° | DZE | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| February 28, 2017 | K161655 | On1 Concept | NHA | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| January 31, 2017 | K163122 | NobelClinician, DTX Studio implant | LLZ | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| November 22, 2016 | K162043 | NobelProcera HT ML FCZ Bridge | ELL | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| November 22, 2016 | K161435 | Temporary Snap Abutment | NHA | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| November 10, 2016 | K161634 | IPS CaseDesigner | LLZ | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| July 25, 2016 | K160158 | NobelProcera HT ML FCZ Implant Bridge and Framework | NHA | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| June 6, 2016 | K153534 | NobelProcera HT ML Full Contour Zirconia Crown | ELL | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| June 2, 2016 | K160119 | NobelSpeedy Groovy | DZE | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| June 2, 2016 | K153036 | NobelDesign Software | NHA | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| March 16, 2016 | K152093 | NobelZygoma 45° | DZE | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| July 24, 2014 | K132749 | NOBELPROCERA OVERDENTURE BAR | NHA | Substantially Equivalent | Nobel Biocare USA, LLC | accessdata.fda.gov |
| May 8, 2014 | K133731 | NOBELACTIVE WIDE PLATFORM (WP) | DZE | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| January 30, 2014 | K132746 | NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT CONICAL CONNECTION | NHA | Substantially Equivalent | Nobel Biocare USA, LLC | accessdata.fda.gov |
| June 5, 2013 | K120954 | NOBELPROCERA PEEK ABUTMENTS | NHA | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| October 28, 2011 | K112259 | NOBELACTIVE 3.0 GOLDADAPT ABUTMENTS | NHA | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| June 23, 2011 | K111581 | 15 ESTHETIC ABUTMENT NOBELACTIVE 03.0 1.5MM, 15 ESTHETIC ABUTMENT NOBELACTIVE 03.0 3MM, 15 ESTHETIC ABUTMENT NOBELACTIVE | NHA | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| December 9, 2010 | K102436 | NOBEL ACTIVE 3.0 | DZE | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| October 6, 2009 | K091907 | NOBELPROCERA IMPLANT BRIDGE ZIRCONIA | NHA | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| September 22, 2009 | K091756 | NOBELPROCERA TI ABUTMENT | NHA | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| June 2, 2009 | K090630 | NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION) | FZE | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| February 13, 2009 | K083205 | NOBELACTIVE 8.5 MM & 18.0 MM | DZE | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| November 19, 2008 | K083100 | GOLDADAPT NON-ENGAGING NOBELACTIVE NP & RP, GOLDADAPT ENGAGING NOBELACTIVE NP & RP | NHA | Substantially Equivalent | Nobel Biocare USA, LLC | accessdata.fda.gov |
| December 28, 2007 | K072570 | NOBELACTIVE MULTI UNIT ABUTMENT | NHA | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| August 3, 2007 | K071370 | NOBELACTIVE INTERNAL CONNECTION IMPLANT | DZE | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| December 6, 2006 | K062566 | NOBELREPLACE TAPERED CONICAL CONNECTION | DZE | Substantially Equivalent | Nobel Biocare USA, LLC | accessdata.fda.gov |
| June 30, 2006 | K061003 | SFB & CFB IMPLANTS | DZE | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| January 27, 2006 | K053091 | PROCERA IMPLANT BRIDGE ZIRCONIA | NHA | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| December 23, 2005 | K052885 | ZYGOMA 17 ABUTMENT MULTI-UNIT RP 2MM, MODEL 29314; ZYGOMA 17 ABUTMENT MULTI-UNIT RP 3MM, MODEL 29315 | NHA | Substantially Equivalent | Nobel Biocare USA, LLC | accessdata.fda.gov |
| June 8, 2005 | K050406 | NOBELSPEEDY IMPLANTS | DZE | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| April 7, 2005 | K050641 | ZYGOMA TIUNITE | NHA | Substantially Equivalent | Nobel Biocare USA, LLC | accessdata.fda.gov |
| May 27, 2004 | K041275 | PROCERA ABUTMENT OCTAGON | NHA | Substantially Equivalent | Nobel Biocare Uas, Inc. | accessdata.fda.gov |
| May 26, 2004 | K041236 | PROCERA IMPLANT BRIDGE, MODELS 15-1001, 15-1002, 15-1051, 15-1052 | NHA | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| July 2, 2003 | K031719 | ESTHETIC ZIRCONIA ABUTMENT | NHA | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| October 11, 2002 | K022562 | VARIOUS BRANEMARK SYSTEM IMPLANTS-IMMEDIATE FUNCTION INDICATION | DZE | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| September 26, 2002 | K023113 | REPLACE TIUNITE ENDOSSEOUS IMPLANT | DZE | Substantially Equivalent | Nobel Biocare Uas, Inc. | accessdata.fda.gov |
| May 29, 2002 | K020646 | REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132, & 60162 | DZE | Substantially Equivalent | Nobel Biocare Uas, Inc. | accessdata.fda.gov |
| June 28, 2001 | K011061 | SURGICAL CONTRA-ANGEL HANDPIECES TYPES WS-56E,WS-75E/KM,WS-92 E/3,SURGICAL STRAIGHT HANDPIECES TYPES, S-9, S-10, S-11 | EGS | Substantially Equivalent | W&H Dentalwerk Buermoos GmbH | accessdata.fda.gov |
| March 30, 2000 | K000018 | BRANEMARK NOVUM | DZE | Substantially Equivalent | Nobel Biocare Uas, Inc. | accessdata.fda.gov |
| November 23, 1999 | K992538 | AMORPHOUS DIAMOND COATED SCREW | DZE | Substantially Equivalent | Nobel Biocare Uas, Inc. | accessdata.fda.gov |
| October 16, 1997 | K970499 | BRANEMARK SYSTEM ZYGOMATICUS FIXTURE SYSTEM | DZE | Substantially Equivalent | Nobel Biocare Uas, Inc. | accessdata.fda.gov |
| September 12, 1997 | K972475 | AURADAPT AUBTMENT SYSTEM | NHA | Substantially Equivalent | Nobel Biocare Uas, Inc. | accessdata.fda.gov |
| March 31, 1997 | K964739 | STERI-OSS TIODIZED SCREW | DZE | Substantially Equivalent | Steri-Oss, Inc. | accessdata.fda.gov |
| March 5, 1997 | K964220 | REPLACE TITANIUM IMPLANT SYSTEM | DZE | Substantially Equivalent | Steri-Oss, Inc. | accessdata.fda.gov |
| February 11, 1997 | K963945 | STERI-OSS GOLD ATTACHMENT SYSTEM | DZE | Substantially Equivalent | Steri-Oss, Inc. | accessdata.fda.gov |
| August 5, 1994 | K913255 | CERAMIC(TM) ABUTMENT | DZE | Substantially Equivalent | Ceramic Core Corp. | accessdata.fda.gov |
| December 10, 1993 | K923695 | STERI-OSS SCREW STYLE CP TITANIUM IMPLANT | DZE | Substantially Equivalent | Steri-Oss, Inc. | accessdata.fda.gov |
| October 20, 1993 | K925767 | BRANEMARK SYSTEM SINGLE TOOTH ABUTMENTS,INST&COMP. | DZE | Substantially Equivalent | Nobelpharma USA, Inc. | accessdata.fda.gov |
| July 22, 1993 | K911592 | STERI-OSS TITANIUM PLAMA SPRAY CYLINDRICAL IMPLANT | DZE | Substantially Equivalent | Steri-Oss, Inc. | accessdata.fda.gov |
| April 20, 1993 | K925779 | BRANEMARK SYSTEM TITANIUM HEALING ABUTMENTS | NHA | Substantially Equivalent | Nobelpharma USA, Inc. | accessdata.fda.gov |
| April 14, 1993 | K925771 | BRANEMARK SYSTEM TITANIUM COVER SCREWS | DZE | Substantially Equivalent | Nobelpharma USA, Inc. | accessdata.fda.gov |
| August 27, 1992 | K905434 | ANGULATED ABUTMENT, COMPLETE,TITANIUM SDCA 102 | DZE | Substantially Equivalent | Nobelpharma USA, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 10, 2025 | 96047 | Class II | Ongoing | . 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 endosseous dental implant in | Due to manufacturing issue (unintended by-product of the injection molding process) a sharp pin that may puncture the blister packaging and breaching the sterile barrier of the finished product. | accessdata.fda.gov |
| July 25, 2022 | 90679 | Class II | Ongoing | Nobel Biocare N1 TiUltra TCC NP 3.5x13mm | Due to the presence of a burr which may cause an aspiration risk to patient during surgical procedure. | accessdata.fda.gov |
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Updated September 8, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.