Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Zimmer Dental, Inc. — Predicate Candidate Screening

40 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

100 daysmedian FDA review time

241 days90th percentile

40clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K160398	MRI Compatibility for Existing Zimmer Dental Implant Systems	Zimmer Dental, Inc.	2017-05-17	460	0
K143505	Zimmer Patient-Specific Abutment, Internal Hex, Titanium	Zimmer Dental, Inc.	2015-06-25	197	0
K143528	Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant	Zimmer Dental, Inc.	2015-05-01	140	0
K142572	Zimmer Zfx Abutment for Zimmer 3.1mmD Implant System	Zimmer Dental, Inc.	2015-01-21	131	0
K142082	ZIMMER 3.1MM DENTAL IMPLANT;2.9MM ANGLED ABUTMENT;STRAIGHT H	Zimmer Dental, Inc.	2014-10-28	89	0
K141544	ZIMMER ZFX TITANIUM ABUTMENT FOR BIOMET 3I CERTAIN IMPLANT S	Zimmer Dental, Inc.	2014-10-22	134	0
K141120	ZIMMER ZFX TITANIUM ABUTMENT FOR STRAUMANN BONE LEVEL IMPLAN	Zimmer Dental, Inc.	2014-07-29	90	0
K133551	ZIMMER ZFX TITANIUM BASE ABUTMENT FOR TAPERED SCREWVENT IMPL	Zimmer Dental, Inc.	2014-07-18	241	0
K134045	ZIMMER ZFX TITANIUM ABUTMENT, BASE ABUTMENT AND ABUTMENT BLA	Zimmer Dental, Inc.	2014-04-25	115	0
K133339	ZIMMER DENTAL TAPERED SCREW VENT T IMPLANT, HA COATED;ZIMMER	Zimmer Dental, Inc.	2014-03-04	125	0
K132258	ZIMMER DENTAL TRABECULAR METAL IMPLANT SYSTEM	Zimmer Dental, Inc.	2013-11-19	123	0
K120873	ZIMMER ZFX ABUTMENT FOR NOBEL REPLACE IMPLANT SYSTEM	Zimmer Dental, Inc.	2012-11-08	231	0
K121709	ZFX DENTAL CAD SYSTEM	Zimmer Dental, Inc.	2012-10-19	130	0
K113753	ZIMMER DENTAL TAPERED SCREW-VENT X	Zimmer Dental, Inc.	2012-08-30	253	0
K113092	ZIMMER CONTOUR PROVISIONAL COPING	Zimmer Dental, Inc.	2012-01-23	96	0
K112160	TAPERED SCREW-VENT X IMPLANT	Zimmer Dental, Inc.	2011-12-14	140	19
K111853	ANGLED TAPERED ABUTMENT	Zimmer Dental, Inc.	2011-12-08	162	0
K111889	ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANT	Zimmer Dental, Inc.	2011-12-06	158	0
K111852	ANODIZED HEALING COLLAR	Zimmer Dental, Inc.	2011-08-11	43	0
K101880	TAPERED SCREW-VENT T IMPLANT, TAPERED SCREW-VENT P IMPLANT	Zimmer Dental, Inc.	2010-10-01	87	1
K101977	TAPERED SCREW-VENT T IMPLANT	Zimmer Dental, Inc.	2010-09-14	62	2
K093164	3.25 SPLINE TWIST IMPLANT, HA COATED	Zimmer Dental, Inc.	2009-12-15	70	1
K092377	PLASTIC TEMPORARY ABUTMENTS, MODELS: PT341S, PT344S, PT341A,	Zimmer Dental, Inc.	2009-11-03	90	0
K092403	TI PREPABLE ABUTMENT, MODEL 1618, 1619, 1620	Zimmer Dental, Inc.	2009-10-30	85	0
K090723	HEX-LOCK SHORT ABUTMENT, MODEL SA341, SA342, SA451, SA452, S	Zimmer Dental, Inc.	2009-04-07	29	0
K083474	ZIMMER ANGLED CONTOUR ZIRCONIA ABUTMENT	Zimmer Dental, Inc.	2008-12-23	29	0
K082639	ZIMMER DENTAL TAPERED SWISSPLUS IMPLANTS	Zimmer Dental, Inc.	2008-12-19	100	0
K080164	ZIMMER PATIENT-SPECIFIC CERAMIC ABUTMENT	Zimmer Dental, Inc.	2008-09-25	246	0
K072589	TAPERED SCREW-VENT IMPLANT, 4.1MM, MODELS: TSV4B8, B10, B11,	Zimmer Dental, Inc.	2007-10-04	20	3
K071439	ZIMMER PATIENT-SPECIFIC ABUTMENT, INTERNAL HEX, TITANIUM	Zimmer Dental, Inc.	2007-09-20	120	0
K071235	ZIMMER ONE PIECE IMPLANT, 3.0MM ANGLED, MODELS ZOP30A10, ZOP	Zimmer Dental, Inc.	2007-05-30	27	0
K063523	ZIMMER ONE PIECE IMPLANT, 3.7MM AND 4.7MM, MODELS ZOP37S10,	Zimmer Dental, Inc.	2007-02-16	86	0
K061847	ZIMMER CONTOUR CERAMIC ABUTMENT, MODELS ZRA341S, ZRA342S, KR	Zimmer Dental, Inc.	2006-10-12	104	0
K061410	SCREW-VENT IMPLANT SYSTEM, SV;TAPERED SCREW -VENT IMPLANT SY	Zimmer Dental, Inc.	2006-09-08	109	1
K061717	ZIMMER ONE-PIECE IMPLANT, 3.7 MM, ANGLED	Zimmer Dental, Inc.	2006-09-08	81	0
K062281	ZIMMER ONE-PIECE IMPLANT, 4.7MM, STRAIGHT, MODELS ZOP47S10,	Zimmer Dental, Inc.	2006-09-05	29	0
K061043	ZIMMER CONTOUR RESTORATIVE SYSTEM	Zimmer Dental, Inc.	2006-06-27	74	0
K060880	ZIMMER DENTAL ONE PIECE TAPERED ABUTMENT, MODELS TAC1, TACW1	Zimmer Dental, Inc.	2006-05-17	47	0
K052997	ZIMMER DENTAL ONE-PIECE IMPLANT	Zimmer Dental, Inc.	2006-01-23	90	0
K052600	ZIMMER DENTAL HEX-LOCK PREPARED ABUTMENT (STRAIGHT & ANGLED)	Zimmer Dental, Inc.	2005-10-13	22	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda