Zimmer Dental Inc

FDA Regulatory Profile

Summary

Total Recalls
33
510(k) Clearances
40
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2963-2018Class IIOuter Package Label: Tapered Screw-Vent Implant System, 4.1mm X 10mm, 3.5mm, REF:TSVM4B10, Sterile:RMay 10, 2018
Z-1189-2018Class IITapered Screw-Vent MTX, Dental Implant, sterile. Model TSVTB10.November 29, 2017
Z-1190-2018Class IITapered Screw-Vent MTX, Dental Implant, sterile. Model TSV4B10.November 29, 2017
Z-0284-2018Class IITapered Screw-Vent MTX Model TSVTB11November 20, 2017
Z-0279-2018Class IIZimmer Dental GemLock RHD2.5 Hex Driver. The label shows the product is Manufactured by Zimmer DentOctober 11, 2017
Z-0281-2018Class IIZimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgical kit, starter, Ref STOctober 11, 2017
Z-0282-2018Class IIZimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgical kit, Complete, Ref TOctober 11, 2017
Z-0280-2018Class IIZimmer Dental Tapered SwissPlus & SwissPlus Implant Systems surgical kit, Ref OPCST. The label showsOctober 11, 2017
Z-3204-2017Class IIGuide Sleeve 3.25 REF 2220, Guide Sleeve 3.75 REF 2221, Guide Sleeve REF 2222, Guide Sleeve REF 2223July 10, 2017
Z-3206-2017Class IIABUT GOLD FRICTION-FIT, REF HLA3G; ABUT GOLD FRICTION-FIT, REF HLA4G; COPING GOLD ENG 5.7 MM, REFJuly 10, 2017
Z-3208-2017Class IIIMPRESSION CAP CONT 3.5MM, REF ZOCIMP3A; MPRESSION CAP CONT 3.5MM, REF ZOCIMP3S; IMPRESSION CAJuly 10, 2017
Z-3207-2017Class IITRY-IN,ABUTMENT, CONT, 3.5X4.5, REF ZOAT34; TRY-IN, ABUTMENT, CONT, 4.5X5.5, REF ZOAT45; TRY-IJuly 10, 2017
Z-3210-2017Class IIIMPLANT,1-PC,ANG,3.0X10MM, REF ZOP30A10; IMPLANT, 1-PC, ANG, 3.0X11.5MM, REF ZOP30A11; IMPLANTJuly 10, 2017
Z-3209-2017Class IIWAXING COPING, CONT 3.5 MM,ANG, REF ZOCWAX3A; WAXING COPING, CONT 3.5 MM, REF ZOCWAX3S; WAXING COPJuly 10, 2017
Z-3205-2017Class IITHREAD RETRIEVAL DRILL REF 2224July 10, 2017
Z-1823-2017Class IITapered SwissPlus Implant System, Model No. SPB10March 20, 2017
Z-0781-2016Class IIIMPLANT,TM, MTX FULL 3.7 mm x 10 mm diameter 3.5 mm Catalog #TMTB10 Product Usage: Zimmer DenJanuary 6, 2016
Z-0774-2016Class IIIMPLANT,TM, MTX 4.1 mm x 13 mm diameter 3.5 mm Catalog #TMM4B13 Product Usage: Zimmer Dental January 6, 2016
Z-0783-2016Class IIIMPLANT,TM, MTX FULL 3.7 mm x 13 mm diameter 3.5 mm Catalog #TMTB13 Product Usage: Zimmer DenJanuary 6, 2016
Z-0778-2016Class IIIMPLANT,TM, MTX FULL 4.1 mm x 10 mm diameter 3.5 mm Catalog #TMT4B10 Product Usage: Zimmer DeJanuary 6, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K160398MRI Compatibility for Existing Zimmer Dental Implant SystemsMay 17, 2017
K143505Zimmer Patient-Specific Abutment, Internal Hex, TitaniumJune 25, 2015
K143528Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant SystemMay 1, 2015
K142572Zimmer Zfx Abutment for Zimmer 3.1mmD Implant SystemJanuary 21, 2015
K142082ZIMMER 3.1MM DENTAL IMPLANT;2.9MM ANGLED ABUTMENT;STRAIGHT HEX, 2.9MM CONTOUR ABUTEMENTOctober 28, 2014
K141544ZIMMER ZFX TITANIUM ABUTMENT FOR BIOMET 3I CERTAIN IMPLANT SYSTEMOctober 22, 2014
K141120ZIMMER ZFX TITANIUM ABUTMENT FOR STRAUMANN BONE LEVEL IMPLANT SYSTEMJuly 29, 2014
K133551ZIMMER ZFX TITANIUM BASE ABUTMENT FOR TAPERED SCREWVENT IMPLANT SYSTEMJuly 18, 2014
K134045ZIMMER ZFX TITANIUM ABUTMENT, BASE ABUTMENT AND ABUTMENT BLANK FOR NOBELACTIVE IMPLANT SYSTEMApril 25, 2014
K133339ZIMMER DENTAL TAPERED SCREW VENT T IMPLANT, HA COATED;ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANT, HAMarch 4, 2014
K132258ZIMMER DENTAL TRABECULAR METAL IMPLANT SYSTEMNovember 19, 2013
K120873ZIMMER ZFX ABUTMENT FOR NOBEL REPLACE IMPLANT SYSTEMNovember 8, 2012
K121709ZFX DENTAL CAD SYSTEMOctober 19, 2012
K113753ZIMMER DENTAL TAPERED SCREW-VENT XAugust 30, 2012
K113092ZIMMER CONTOUR PROVISIONAL COPINGJanuary 23, 2012
K112160TAPERED SCREW-VENT X IMPLANTDecember 14, 2011
K111853ANGLED TAPERED ABUTMENTDecember 8, 2011
K111889ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANTDecember 6, 2011
K111852ANODIZED HEALING COLLARAugust 11, 2011
K101880TAPERED SCREW-VENT T IMPLANT, TAPERED SCREW-VENT P IMPLANTOctober 1, 2010