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

Nobel Biocare Uas, Inc. — Predicate Candidate Screening

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

86 daysmedian FDA review time

182 days90th percentile

31clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K050444	NOBELREPLACE ADAPTER, MODEL 32412	Nobel Biocare Uas, Inc.	2005-07-07	135	0
K042658	PROCERA ABUTMENT BRANEMARK, MODELS 10-4001, 10-4004, 10-5001	Nobel Biocare Uas, Inc.	2004-10-20	22	0
K041661	NOBEL BIOCARE ENDOSSEOUS IMPLANTS	Nobel Biocare Uas, Inc.	2004-08-26	69	0
K041876	NOBELDIRECT OD IMPLANT	Nobel Biocare Uas, Inc.	2004-08-20	39	0
K041312	NOBELRONDO DENTAL CERAMIC-ALUMINA	Nobel Biocare Uas, Inc.	2004-07-23	67	0
K041275	PROCERA ABUTMENT OCTAGON	Nobel Biocare Uas, Inc.	2004-05-27	15	0
K040573	NOBEL BIOCARE PERMANENT CENTRIC POST, MODELS 31234, 31235, 3	Nobel Biocare Uas, Inc.	2004-04-28	55	0
K033724	NOBEL BIOCARE CENTRIC POST, MODELS 31234, 31235 AND 31236	Nobel Biocare Uas, Inc.	2004-02-23	89	0
K031345	NOBEL DIRECT, MODELS 30937, 30938	Nobel Biocare Uas, Inc.	2003-07-24	86	0
K030257	NOBEL PERFECT IMPLANT SYSTEM	Nobel Biocare Uas, Inc.	2003-02-10	17	0
K023952	REPLACE ONE PIECE IMPLANT, HA, REPLACE ONE PIECE IMPLANT, TI	Nobel Biocare Uas, Inc.	2003-01-16	50	0
K022424	REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102	Nobel Biocare Uas, Inc.	2002-09-27	65	0
K023113	REPLACE TIUNITE ENDOSSEOUS IMPLANT	Nobel Biocare Uas, Inc.	2002-09-26	7	27
K021584	REPLACE SCALLOPED MARGIN IMPLANT SYSTEM	Nobel Biocare Uas, Inc.	2002-06-05	22	0
K020646	REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102	Nobel Biocare Uas, Inc.	2002-05-29	90	0
K002475	REPLACE TPS COATED IMPLANTS	Nobel Biocare Uas, Inc.	2000-11-09	90	0
K000643	INPLANT ORTHODONTIC ANCHOR SYSTEM	Nobel Biocare Uas, Inc.	2000-09-07	195	0
K000018	BRANEMARK NOVUM	Nobel Biocare Uas, Inc.	2000-03-30	86	0
K992937	DENTAL IMPLANT	Nobel Biocare Uas, Inc.	2000-02-29	182	0
K993595	NOBEL BIOCARE'S MODIFIED SURFACE IMPLANT (INTENDED FOR IMMED	Nobel Biocare Uas, Inc.	2000-01-28	95	0
K992538	AMORPHOUS DIAMOND COATED SCREW	Nobel Biocare Uas, Inc.	1999-11-23	116	0
K990846	AMORPHOUS DIAMOND COATED DRILL	Nobel Biocare Uas, Inc.	1999-06-10	87	14
K984287	PROVISIONAL DENTAL IMPLANT SYSTEM	Nobel Biocare Uas, Inc.	1999-03-01	90	0
K983453	PROCERA ALLCERAM FUSING MATERIAL	Nobel Biocare Uas, Inc.	1998-11-18	49	0
K974123	BRANEMARK SYSTEM DEC 600 DRILLING UNIT	Nobel Biocare Uas, Inc.	1998-05-26	204	0
K980460	ONPLANT ORTHODONTIC SYSTEM	Nobel Biocare Uas, Inc.	1998-05-05	92	0
K974828	BRANEMARK SYSTEM(R) EBON(TM) FIXTURE	Nobel Biocare Uas, Inc.	1998-03-24	90	0
K974150	PROCERA PREPARABLE ABUTMENT SYSTEM	Nobel Biocare Uas, Inc.	1998-01-23	80	0
K970499	BRANEMARK SYSTEM ZYGOMATICUS FIXTURE SYSTEM	Nobel Biocare Uas, Inc.	1997-10-16	248	0
K972475	AURADAPT AUBTMENT SYSTEM	Nobel Biocare Uas, Inc.	1997-09-12	73	0
K971706	TIADAPT ABUTMENT SYSTEM	Nobel Biocare Uas, Inc.	1997-07-21	74	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