Zimmer Dental, Inc.
Zimmer Dental, Inc. holds FDA 510(k) medical device clearances, first cleared 2005, most recent 2017, with 33 FDA device recalls on record.
Top product codes for Zimmer Dental, Inc.
FDA recalls by Zimmer Dental, Inc.
10 most recent of 33- Z-2963-2018 — 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 Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
- Z-1190-2018 — Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSV4B10.
- Z-1189-2018 — Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSVTB10.
- Z-0284-2018 — Tapered Screw-Vent MTX Model TSVTB11
- Z-0282-2018 — 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 dental implant accessories are manually powered devices intended to aid in the placement or removal of endosseous dental implants and abutments, prepare the site for placement of endosseous dental implants or abutments, aid in the fitting of endosseous dental implants or abutments, aid in the fabrication of dental prosthetics, and be used as an accessory with endosseous dental implants when tissue contact will last less than 1 hour.
- Z-0279-2018 — 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 to aid in the placement or removal of endosseous dental implants and abutments, prepare the site for placement of endosseous dental implants or abutments, aid in the fitting of endosseous dental implants or abutments, aid in the fabrication of dental prosthetics, and be used as an accessory with endosseous dental implants when tissue contact will last less than 1 hour.
- Z-0280-2018 — 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 accessories are manually powered devices intended to aid in the placement or removal of endosseous dental implants and abutments, prepare the site for placement of endosseous dental implants or abutments, aid in the fitting of endosseous dental implants or abutments, aid in the fabrication of dental prosthetics, and be used as an accessory with endosseous dental implants when tissue contact will last less than 1 hour.
- Z-0281-2018 — 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 dental implant accessories are manually powered devices intended to aid in the placement or removal of endosseous dental implants and abutments, prepare the site for placement of endosseous dental implants or abutments, aid in the fitting of endosseous dental implants or abutments, aid in the fabrication of dental prosthetics, and be used as an accessory with endosseous dental implants when tissue contact will last less than 1 hour.
- Z-3209-2017 — 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, 5.5MM,ANG, REF ZOCWAX5A; WAXING COPING, CONT, 5.5MM, REF ZOCWAX5S; WAXING COPING, CONT, 6.5MM,ANG, REF ZOCWAX6A; WAXING COPING, CONT, 6.5MM, REF ZOCWAX6S
- Z-3205-2017 — THREAD RETRIEVAL DRILL REF 2224
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Zimmer Dental, Inc.
- K160398 — MRI Compatibility for Existing Zimmer Dental Implant Systems
- K143505 — Zimmer Patient-Specific Abutment, Internal Hex, Titanium
- K143528 — Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System
- K142572 — Zimmer Zfx Abutment for Zimmer 3.1mmD Implant System
- K142082 — ZIMMER 3.1MM DENTAL IMPLANT; 2.9MM ANGLED ABUTMENT; STRAIGHT HEX, 2.9MM CONTOUR ABUTEMENT
- K141544 — ZIMMER ZFX TITANIUM ABUTMENT FOR BIOMET 3I CERTAIN IMPLANT SYSTEM
- K141120 — ZIMMER ZFX TITANIUM ABUTMENT FOR STRAUMANN BONE LEVEL IMPLANT SYSTEM
- K133551 — ZIMMER ZFX TITANIUM BASE ABUTMENT FOR TAPERED SCREWVENT IMPLANT SYSTEM
- K134045 — ZIMMER ZFX TITANIUM ABUTMENT, BASE ABUTMENT AND ABUTMENT BLANK FOR NOBELACTIVE IMPLANT SYSTEM
- K133339 — ZIMMER DENTAL TAPERED SCREW VENT T IMPLANT, HA COATED; ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANT, HA COATED
- K132258 — ZIMMER DENTAL TRABECULAR METAL IMPLANT SYSTEM
- K120873 — ZIMMER ZFX ABUTMENT FOR NOBEL REPLACE IMPLANT SYSTEM
- K121709 — ZFX DENTAL CAD SYSTEM
- K113753 — ZIMMER DENTAL TAPERED SCREW-VENT X
- K113092 — ZIMMER CONTOUR PROVISIONAL COPING
- K112160 — TAPERED SCREW-VENT X IMPLANT
- K111853 — ANGLED TAPERED ABUTMENT
- K111889 — ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANT
- K111852 — ANODIZED HEALING COLLAR
- K101880 — TAPERED SCREW-VENT T IMPLANT, TAPERED SCREW-VENT P IMPLANT
- K101977 — TAPERED SCREW-VENT T IMPLANT
- K093164 — 3.25 SPLINE TWIST IMPLANT, HA COATED
- K092377 — PLASTIC TEMPORARY ABUTMENTS, MODELS: PT341S, PT344S, PT341A, PT344A, PT451S, PT454S, PT451A, PT454A, PT561S, PT564S
- K092403 — TI PREPABLE ABUTMENT, MODEL 1618, 1619, 1620
- K090723 — HEX-LOCK SHORT ABUTMENT, MODEL SA341, SA342, SA451, SA452, SA561, SA562 SHORT HEALING CAP, MODEL SAHEAL4, SAHEAL5,
- K083474 — ZIMMER ANGLED CONTOUR ZIRCONIA ABUTMENT
- K082639 — ZIMMER DENTAL TAPERED SWISSPLUS IMPLANTS
- K080164 — ZIMMER PATIENT-SPECIFIC CERAMIC ABUTMENT
- K072589 — TAPERED SCREW-VENT IMPLANT, 4.1MM, MODELS: TSV4B8, B10, B11, B13 AND B16, TSV4H8, H11, H13 AND H16
- K071439 — ZIMMER PATIENT-SPECIFIC ABUTMENT, INTERNAL HEX, TITANIUM
- K071235 — ZIMMER ONE PIECE IMPLANT, 3.0MM ANGLED, MODELS ZOP30A10, ZOP30A11 AND ZOP30A13
- K063523 — ZIMMER ONE PIECE IMPLANT, 3.7MM AND 4.7MM, MODELS ZOP37S10, 11, 13, 16; ZOP37A10, 11, 13, 16; ZOP47S10, 11, 13, 16
- K061847 — ZIMMER CONTOUR CERAMIC ABUTMENT, MODELS ZRA341S, ZRA342S, KRA451S, ZRA452S
- K061410 — SCREW-VENT IMPLANT SYSTEM, SV +3 more
- K061717 — ZIMMER ONE-PIECE IMPLANT, 3.7 MM, ANGLED
- K062281 — ZIMMER ONE-PIECE IMPLANT, 4.7MM, STRAIGHT, MODELS ZOP47S10, ZOP47S11, ZOP47S13, ZOP47S16
- K061043 — ZIMMER CONTOUR RESTORATIVE SYSTEM
- K060880 — ZIMMER DENTAL ONE PIECE TAPERED ABUTMENT, MODELS TAC1, TACW1, TA5C1
- K052997 — ZIMMER DENTAL ONE-PIECE IMPLANT
- K052600 — ZIMMER DENTAL HEX-LOCK PREPARED ABUTMENT (STRAIGHT & ANGLED)
Data sourced from openFDA. This site is unofficial and independent of the FDA.