Company ยท US
Zimmer Dental, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2017. Name variants (Inc, Corp, punctuation) are merged.
40510(k) clearances (0 in 12 months)
40recalls (0 in 12 months)
23recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 17, 2017 | K160398 | MRI Compatibility for Existing Zimmer Dental Implant Systems Zimmer Dental, Inc. | DZE |
| Jun 25, 2015 | K143505 | Zimmer Patient-Specific Abutment, Internal Hex, Titanium Zimmer Dental, Inc. | NHA |
| May 1, 2015 | K143528 | Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System Zimmer Dental, Inc. | NHA |
| Jan 21, 2015 | K142572 | Zimmer Zfx Abutment for Zimmer 3.1mmD Implant System Zimmer Dental, Inc. | NHA |
| Oct 28, 2014 | K142082 | ZIMMER 3.1MM DENTAL IMPLANT;2.9MM ANGLED ABUTMENT;STRAIGHT HEX, 2.9MM CONTOUR ABUTEMENT Zimmer Dental, Inc. | DZE |
| Oct 22, 2014 | K141544 | ZIMMER ZFX TITANIUM ABUTMENT FOR BIOMET 3I CERTAIN IMPLANT SYSTEM Zimmer Dental, Inc. | NHA |
| Jul 29, 2014 | K141120 | ZIMMER ZFX TITANIUM ABUTMENT FOR STRAUMANN BONE LEVEL IMPLANT SYSTEM Zimmer Dental, Inc. | NHA |
| Jul 18, 2014 | K133551 | ZIMMER ZFX TITANIUM BASE ABUTMENT FOR TAPERED SCREWVENT IMPLANT SYSTEM Zimmer Dental, Inc. | NHA |
| Apr 25, 2014 | K134045 | ZIMMER ZFX TITANIUM ABUTMENT, BASE ABUTMENT AND ABUTMENT BLANK FOR NOBELACTIVE IMPLANT SYSTEM Zimmer Dental, Inc. | NHA |
| Mar 4, 2014 | K133339 | ZIMMER DENTAL TAPERED SCREW VENT T IMPLANT, HA COATED;ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANT, HA COATED Zimmer Dental, Inc. | DZE |
| Nov 19, 2013 | K132258 | ZIMMER DENTAL TRABECULAR METAL IMPLANT SYSTEM Zimmer Dental, Inc. | DZE |
| Nov 8, 2012 | K120873 | ZIMMER ZFX ABUTMENT FOR NOBEL REPLACE IMPLANT SYSTEM Zimmer Dental, Inc. | NHA |
| Oct 19, 2012 | K121709 | ZFX DENTAL CAD SYSTEM Zimmer Dental, Inc. | NHA |
| Aug 30, 2012 | K113753 | ZIMMER DENTAL TAPERED SCREW-VENT X Zimmer Dental, Inc. | DZE |
| Jan 23, 2012 | K113092 | ZIMMER CONTOUR PROVISIONAL COPING Zimmer Dental, Inc. | NHA |
| Dec 14, 2011 | K112160 | TAPERED SCREW-VENT X IMPLANT Zimmer Dental, Inc. | DZE |
| Dec 8, 2011 | K111853 | ANGLED TAPERED ABUTMENT Zimmer Dental, Inc. | NHA |
| Dec 6, 2011 | K111889 | ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANT Zimmer Dental, Inc. | DZE |
| Aug 11, 2011 | K111852 | ANODIZED HEALING COLLAR Zimmer Dental, Inc. | NHA |
| Oct 1, 2010 | K101880 | TAPERED SCREW-VENT T IMPLANT, TAPERED SCREW-VENT P IMPLANT Zimmer Dental, Inc. | DZE |
| Sep 14, 2010 | K101977 | TAPERED SCREW-VENT T IMPLANT Zimmer Dental, Inc. | DZE |
| Dec 15, 2009 | K093164 | 3.25 SPLINE TWIST IMPLANT, HA COATED Zimmer Dental, Inc. | DZE |
| Nov 3, 2009 | K092377 | PLASTIC TEMPORARY ABUTMENTS, MODELS: PT341S, PT344S, PT341A, PT344A, PT451S, PT454S, PT451A, PT454A, PT561S, PT564S Zimmer Dental, Inc. | NHA |
| Oct 30, 2009 | K092403 | TI PREPABLE ABUTMENT, MODEL 1618, 1619, 1620 Zimmer Dental, Inc. | NHA |
| Apr 7, 2009 | K090723 | HEX-LOCK SHORT ABUTMENT, MODEL SA341, SA342, SA451, SA452, SA561, SA562 SHORT HEALING CAP, MODEL SAHEAL4, SAHEAL5, Zimmer Dental, Inc. | NHA |
| Dec 23, 2008 | K083474 | ZIMMER ANGLED CONTOUR ZIRCONIA ABUTMENT Zimmer Dental, Inc. | NHA |
| Dec 19, 2008 | K082639 | ZIMMER DENTAL TAPERED SWISSPLUS IMPLANTS Zimmer Dental, Inc. | DZE |
| Sep 25, 2008 | K080164 | ZIMMER PATIENT-SPECIFIC CERAMIC ABUTMENT Zimmer Dental, Inc. | NHA |
| Oct 4, 2007 | K072589 | TAPERED SCREW-VENT IMPLANT, 4.1MM, MODELS: TSV4B8, B10, B11, B13 AND B16, TSV4H8, H11, H13 AND H16 Zimmer Dental, Inc. | DZE |
| Sep 20, 2007 | K071439 | ZIMMER PATIENT-SPECIFIC ABUTMENT, INTERNAL HEX, TITANIUM Zimmer Dental, Inc. | DZE |
| May 30, 2007 | K071235 | ZIMMER ONE PIECE IMPLANT, 3.0MM ANGLED, MODELS ZOP30A10, ZOP30A11 AND ZOP30A13 Zimmer Dental, Inc. | DZE |
| Feb 16, 2007 | K063523 | ZIMMER ONE PIECE IMPLANT, 3.7MM AND 4.7MM, MODELS ZOP37S10, 11, 13, 16; ZOP37A10, 11, 13, 16; ZOP47S10, 11, 13, 16; ZOP4 Zimmer Dental, Inc. | DZE |
| Oct 12, 2006 | K061847 | ZIMMER CONTOUR CERAMIC ABUTMENT, MODELS ZRA341S, ZRA342S, KRA451S, ZRA452S Zimmer Dental, Inc. | NHA |
| Sep 8, 2006 | K061717 | ZIMMER ONE-PIECE IMPLANT, 3.7 MM, ANGLED Zimmer Dental, Inc. | DZE |
| Sep 8, 2006 | K061410 | SCREW-VENT IMPLANT SYSTEM, SV;TAPERED SCREW -VENT IMPLANT SYSTEM, TSV;ADVENT IMPLANT SYSTEM,AV;ZIMMER ONE-PIECE IMPLANT Zimmer Dental, Inc. | DZE |
| Sep 5, 2006 | K062281 | ZIMMER ONE-PIECE IMPLANT, 4.7MM, STRAIGHT, MODELS ZOP47S10, ZOP47S11, ZOP47S13, ZOP47S16 Zimmer Dental, Inc. | DZE |
| Jun 27, 2006 | K061043 | ZIMMER CONTOUR RESTORATIVE SYSTEM Zimmer Dental, Inc. | NHA |
| May 17, 2006 | K060880 | ZIMMER DENTAL ONE PIECE TAPERED ABUTMENT, MODELS TAC1, TACW1, TA5C1 Zimmer Dental, Inc. | NHA |
| Jan 23, 2006 | K052997 | ZIMMER DENTAL ONE-PIECE IMPLANT Zimmer Dental, Inc. | DZE |
| Oct 13, 2005 | K052600 | ZIMMER DENTAL HEX-LOCK PREPARED ABUTMENT (STRAIGHT & ANGLED) Zimmer Dental, Inc. | NHA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
| 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 |
| Nov 20, 2017 | Zimmer Dental Inc Tapered Screw-Vent MTX Model TSVTB11 Terminated |
DZE | K101977 |
| Oct 11, 2017 | Zimmer Dental Inc Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgical kit, Complete, Ref TSVKIT. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA.
Endosseous Terminated |
NDP | None listed |
| Oct 11, 2017 | Zimmer Dental Inc Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgical kit, starter, Ref STRKIT. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA.
Endosseous Terminated |
NDP | None listed |
| Oct 11, 2017 | Zimmer Dental Inc Zimmer Dental Tapered SwissPlus & SwissPlus Implant Systems surgical kit, Ref OPCST. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA.
Endosseous dental implant access Terminated |
NDP | None listed |
| Oct 11, 2017 | Zimmer Dental Inc Zimmer Dental GemLock RHD2.5 Hex Driver. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA.
Endosseous dental implant accessories are manually powered devices intended Terminated |
NDP | None listed |
| 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 WAXING COPING, CONT 3.5 MM,ANG, REF ZOCWAX3A;
WAXING COPING, CONT 3.5 MM, REF ZOCWAX3S;
WAXING COPING, CONT 4.5MM, ANG, REF ZOCWAX4A;
WAXING COPING, CONT 4.5MM, REF ZOCWAX4S;
WAXING COPING, CONT, Terminated |
NDP | None listed |
| Jul 10, 2017 | Zimmer Dental Inc IMPRESSION CAP CONT 3.5MM, REF ZOCIMP3A;
MPRESSION CAP CONT 3.5MM, REF ZOCIMP3S;
IMPRESSION CAP CONT 4.5MM ANG, REF ZOCIMP4A;
IMPRESSION CAP CONT 4.5MM, REF ZOCIMP4S;
IMPRESSION CAP,CONT,5 Terminated |
NDP | None listed |
| Jul 10, 2017 | Zimmer Dental Inc TRY-IN,ABUTMENT, CONT, 3.5X4.5, REF ZOAT34;
TRY-IN, ABUTMENT, CONT, 4.5X5.5, REF ZOAT45;
TRY-IN, ABUTMENT, CONT, 5.7X6.5, REF ZOAT56;
TRY-IN KIT, ABUTMENT, CONT, REF ZOATKIT Terminated |
NDP | None listed |
| 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 |
| Jul 10, 2017 | Zimmer Dental Inc THREAD RETRIEVAL DRILL REF 2224 Terminated |
DZA | None listed |
| Jul 10, 2017 | Zimmer Dental Inc Guide Sleeve 3.25 REF 2220, Guide Sleeve 3.75 REF 2221, Guide Sleeve REF 2222, Guide Sleeve REF 2223 Terminated |
NDP | None listed |
| Mar 20, 2017 | Zimmer Dental Inc Tapered SwissPlus Implant System, Model No. SPB10 Terminated |
DZE | K082639 |
| Feb 9, 2016 | Zimmer Dental Inc IMPLANT,TM, MTX FULL
3.7 mm x 16 mm
diameter 3.5 mm
Catalog #TMTB16
Product Usage:
Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading a Terminated |
DZE | K112160 |
| Feb 9, 2016 | Zimmer Dental Inc IMPLANT,TM, MTX FULL
3.7 mm x 13 mm
diameter 3.5 mm
Catalog #TMTB13
Product Usage:
Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading a Terminated |
DZE | K112160 |
| Feb 9, 2016 | Zimmer Dental Inc IMPLANT,TM, MTX FULL
3.7 mm x 11.5 mm
diameter 3.5 mm
Catalog #TMTB11
Product Usage:
Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading Terminated |
DZE | K112160 |
| Feb 9, 2016 | Zimmer Dental Inc IMPLANT,TM, MTX FULL
3.7 mm x 10 mm
diameter 3.5 mm
Catalog #TMTB10
Product Usage:
Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading a Terminated |
DZE | K112160 |
| Feb 9, 2016 | Zimmer Dental Inc IMPLANT,TM, MTX FULL
4.1 mm x 13 mm
diameter 3.5 mm
Catalog #TMT4B13
Product Usage:
Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading Terminated |
DZE | K112160 |
| Feb 9, 2016 | Zimmer Dental Inc IMPLANT,TM, MTX FULL
4.1 mm x 11.5 mm
diameter 3.5 mm
Catalog #TMT4B11
Product Usage:
Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loadin Terminated |
DZE | K112160 |
| Feb 9, 2016 | Zimmer Dental Inc IMPLANT,TM, MTX FULL
4.1 mm x 10 mm
diameter 3.5 mm
Catalog #TMT4B10
Product Usage:
Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading Terminated |
DZE | K112160 |
| Feb 9, 2016 | Zimmer Dental Inc IMPLANT,TM, MTX
3.7 mm x 13 mm
diameter 3.5 mm
Catalog #TMMB13
Product Usage:
Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after Terminated |
DZE | K112160 |
| Feb 9, 2016 | Zimmer Dental Inc IMPLANT,TM, MTX
3.7 mm x 11.5 mm
diameter 3.5 mm
Catalog #TMMB11
Product Usage:
Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading afte Terminated |
DZE | K112160 |
| Feb 9, 2016 | Zimmer Dental Inc IMPLANT,TM, MTX
3.7 mm x 10 mm
diameter 3.5 mm
Catalog #TMMB10
Product Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conve Terminated |
DZE | K112160 |
| Feb 9, 2016 | Zimmer Dental Inc IMPLANT,TM, MTX
4.1 mm x 13 mm
diameter 3.5 mm
Catalog #TMM4B13
Product Usage:
Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after Terminated |
DZE | K112160 |
| Feb 9, 2016 | Zimmer Dental Inc IMPLANT,TM, MTX
4.1 mm x 11.5 mm
diameter 3.5 mm
Catalog #TMM4B11
Product Usage:
Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading aft Terminated |
DZE | K112160 |
| Feb 9, 2016 | Zimmer Dental Inc IMPLANT,TM, MTX
4.1 mm x 10 mm
diameter 3.5 mm
Catalog #TMM4B10
Product Usage:
Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after Terminated |
DZE | K112160 |
| Feb 12, 2015 | Zimmer Dental Inc GemLock Long Hex Driver, Catalog RHL2.5; Also distributed within the Tapered SwissPlus & SwissPlus Implant Systems Kits, Surgical, Complete, Catalog OPCST; Tapered Screw-Vent Implant System Surgical K Terminated |
NDP | None listed |
| Oct 30, 2014 | Zimmer Dental Inc Tapered Screw-Vent Implant, MTX, 4.1mmD X 10mmL X 3.5mm Platform
Part No. TSV4B10
Tapered Screw-Vent Implant, MTX, 4.1mmD X 11.5mmL X 3.5mm Platform
Part No. TSV4B11
The Tapered Screw-Vent Implants Terminated |
DZE | K072589 |
| Oct 30, 2014 | Zimmer Dental Inc Spline Twist Implant, HA 3.25mmD X 15mmL; Part No. 2135.
Zimmer Dental Spline implant systems are designed for use in edentulous mandibles or maxillae for attachment of complete denture prostheses fo Terminated |
DZE | K093164 |
| Jan 28, 2014 | Zimmer Dental Inc Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11, Lot 62470008.
Class II, 510(k) K13227. Terminated |
DZE | K072589 |
| Jul 23, 2004 | Zimmer Dental Inc Taperlock Implant Line Terminated |
DZE | None listed |
| Jul 23, 2004 | Zimmer Dental Inc Swissplus Implant Line Terminated |
DZE | None listed |
| Jul 23, 2004 | Zimmer Dental Inc Swedevent Implant Line Terminated |
DZE | None listed |
| Jul 23, 2004 | Zimmer Dental Inc Screwvent Implant Line Terminated |
DZE | None listed |
| Jul 23, 2004 | Zimmer Dental Inc Microvent Implant Line Terminated |
DZE | None listed |
| Jul 23, 2004 | Zimmer Dental Inc Biovent Implant Line Terminated |
DZE | None listed |
| Jul 23, 2004 | Zimmer Dental Inc Advent Implant Line Terminated |
DZE | None listed |