Data / Medical devices / Netherlands / Nobel Biocare Distribution Center BV
Nobel Biocare Distribution Center BV: FDA-registered device maker in Venlo Limburg, Netherlands, 100 510(k) clearances and 1 PMA approval
Nobel Biocare Distribution Center BV is registered with the FDA (registration 3006540014) in Venlo Limburg, Netherlands. It lists 33 device types. The FDA files 100 510(k) clearances and 1 PMA approval under its listings, the newest dated September 8, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3006540014
- Address
- Heierkerkweg 1B, Venlo Limburg, Netherlands, 5928 RM
- Owner or operator
- Nobel Biocare Services AG (8030879)
- Roles
- Complaint file establishment, Exporter to the US
- First device listed
- August 1, 1994
- Registered through
- 2027
- Brand names listed
- 1st Generation Surgical Templates, NobelGuide, 2nd Generation Surgical Templates, NobelGuide, ASSAmed GmbH - Medizinbedarf, ASSAmed Y-Connector, Abutment Blank, Abutment Release Pin, Abutment Replica Multi-unit, Abutment Replica Snappy 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 |
| 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 |
| September 13, 2024 | K241722 | Elos Accurate® Hybrid Base; Elos Accurate® Customized Abutment | NHA | Substantially Equivalent | Elos Medtech Pinol A/S | 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 21, 2023 | K231307 | Elos Accurate Customized Abutment | NHA | Substantially Equivalent | Elos Medtech Pinol A/S | accessdata.fda.gov |
| August 14, 2023 | K231434 | DESS Dental Smart Solutions | NHA | Substantially Equivalent | Terrats Medical SL | 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 |
| October 27, 2022 | K222288 | DESS Dental Smart Solutions | NHA | Substantially Equivalent | Terrats Medical SL | 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 11, 2022 | K212628 | DESS Dental Smart Solutions | NHA | Substantially Equivalent | Terrats Medical SL | 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 10, 2021 | K212577 | DESS Dental Smart Solutions | NHA | Substantially Equivalent | Terrats Medical SL | accessdata.fda.gov |
| July 21, 2021 | K193352 | AbutmentCAD | PNP | Substantially Equivalent | Exocad GmbH | accessdata.fda.gov |
| February 19, 2021 | K201860 | Elos Accurate Hybrid Base | NHA | Substantially Equivalent | Elos Medtech Pinol A/S | accessdata.fda.gov |
| January 23, 2021 | K201187 | Cytoplast Titanium-Reinforced PTFE Membranes | NPK | Substantially Equivalent | Osteogenics Biomedical, Inc. | accessdata.fda.gov |
| December 3, 2020 | K202452 | NobelProcera Zirconia Implant Bridge | NHA | 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 |
| May 21, 2020 | K200662 | X-Guide® Surgical Navigation System | PLV | Substantially Equivalent | X-Nav Technologies, LLC | accessdata.fda.gov |
| March 30, 2020 | K200040 | Universal Base Conical Connection (CC) | NHA | Substantially Equivalent | Nobel Biocare AG | accessdata.fda.gov |
| February 10, 2020 | K191919 | Elos Accurate Hybrid Base | NHA | Substantially Equivalent | Elos Medtech Pinol A/S | accessdata.fda.gov |
| February 6, 2020 | K191890 | Elos Accurate Customized Abutment | NHA | Substantially Equivalent | Elos Medtech Pinol A/S | accessdata.fda.gov |
| February 3, 2020 | K192579 | X-Guide Surgical Navigation System | PLV | Substantially Equivalent | X-Nav Technologies, LLC | accessdata.fda.gov |
| November 10, 2019 | K191986 | DESS Dental Smart Solutions | NHA | Substantially Equivalent | Terrats Medical SL | 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 |
| August 22, 2019 | K181888 | Osstell Beacon | EKX | Substantially Equivalent | Osstell AB | accessdata.fda.gov |
| June 26, 2019 | K190299 | Elos Accurate® Customized Abutment | NHA | Substantially Equivalent | Elos Medtech Pinol A/S | 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 |
| November 16, 2018 | K180184 | Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System | NHA | Substantially Equivalent | Dentalpoint AG | accessdata.fda.gov |
| September 27, 2018 | K181075 | PureSet Tray | KCT | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| December 18, 2017 | K172918 | DEXIS Titanium, KaVo IXS HD (Size 1, Size 2) | MUH | Substantially Equivalent | Kavo Dental Technologies, LLC | accessdata.fda.gov |
| December 14, 2017 | K172854 | NobelPerfect Abutments | NHA | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| November 16, 2017 | K173319 | KaVo NOMAD Pro 2 Handheld X-ray System | EHD | Substantially Equivalent | Aribex | accessdata.fda.gov |
| October 26, 2017 | K171142 | Healing Cap Multi-Unit Titanium | NHA | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| August 8, 2017 | K170588 | DESS Dental Smart Solutions | NHA | Substantially Equivalent | Terrats Medical SL | 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 |
| November 23, 2016 | K161957 | W&H Implantmed SI-1015 incl. Accessories | EBW | Substantially Equivalent | W&H Dentalwerk Burmoos GmbH | accessdata.fda.gov |
| November 22, 2016 | K161435 | Temporary Snap Abutment | NHA | 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 2, 2016 | K160119 | NobelSpeedy Groovy | DZE | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| March 16, 2016 | K152093 | NobelZygoma 45° | DZE | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| July 31, 2015 | K142040 | OCS-B COLLAGEN | NPM | Substantially Equivalent | Nibec Co., Ltd. | accessdata.fda.gov |
| July 24, 2015 | K150295 | LOCATOR RTx | NHA | Substantially Equivalent | Zest Anchors, Inc. | accessdata.fda.gov |
| August 15, 2014 | K140308 | MASTERSURG / EXPERTSURG | EBW | Substantially Equivalent | Kaltenbach & Voigt GmbH | 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 |
| January 16, 2013 | K113246 | OCS-B | NPM | Substantially Equivalent | Nibec Company, Limited | 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 |
| June 23, 2011 | K110724 | SURGICAL PROCEDURE PACKS | FYA | Substantially Equivalent | Omnia Spa | accessdata.fda.gov |
| December 9, 2010 | K102436 | NOBEL ACTIVE 3.0 | DZE | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| December 15, 2009 | K092214 | CHIROPRO L SYSTEM | EBW | Substantially Equivalent | Bien-Air Dental, SA | 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 |
| July 29, 2008 | K080939 | SURGICAL HANDPIECES, MIKRO SAW HANDPIECES | KMW | Substantially Equivalent | W&H Dentalwerk Buermoos GmbH | accessdata.fda.gov |
| December 28, 2007 | K072570 | NOBELACTIVE MULTI UNIT ABUTMENT | NHA | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| December 3, 2007 | K072878 | MODIFICATION TO: LOCATOR IMPLANT ANCHOR | NHA | Substantially Equivalent | Zest Anchors, Inc. | 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 |
| May 3, 2006 | K060287 | DRILLTECH, ISM, IMPLANTUNIT, ZIMMER SURGICAL MOTOR SYSTEM | EBW | Substantially Equivalent | W&H Dentalwerk Buermoos GmbH | 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 |
| April 22, 2004 | K033699 | LOCATOR BAR FEMALE, LOCATOR LASER BAR FEMALE, LOCATOR BAR CAST-TO FEMALE, MODELS 08587, 08588, 08586 | DZE | Substantially Equivalent | Zest Anchors, Inc. | 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 |
| December 10, 1998 | K983183 | GYRO LONG-LIFE,BLACK PEARL ECO, ONDINE &CROMA, PRESTIGE, BORA, AQUILON, MC2,MC3, BASCH, ISOLITE, OPTIMA, US, PLPE, CA, P | EFB | Substantially Equivalent | Bien Air USA, 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 |
| August 6, 1997 | K972278 | CYTOPLAST REGENTEX TITANIUM 250 | LYC | Substantially Equivalent | Osteogenics Co. | accessdata.fda.gov |
| March 31, 1997 | K964739 | STERI-OSS TIODIZED SCREW | DZE | Substantially Equivalent | Steri-Oss, Inc. | accessdata.fda.gov |
| March 11, 1997 | K964342 | CYTOPLAST GBR | LYC | Substantially Equivalent | Osteogenics Co. | 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 |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| November 8, 1985 | P840062 | COLLACOTE(TM) | LPG | 94 | September 18, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Implant, Endosseous, Root-Form
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Handpiece, Contra- And Right-Angle Attachment, Dental
- All makers of Dental Abutment Design Software For Dental Laboratory
- All makers of Unit, X-Ray, Extraoral With Timer
- All makers of Prosthesis, Nose, Internal
Updated September 18, 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.