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

Straumann USA — Predicate Candidate Screening

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

88 daysmedian FDA review time

164 days90th percentile

41clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K151328	PURE Ceramic Implants	Straumann USA	2016-01-11	238	0
K130724	CODIAGNOSTIX IMPLANT PLANNING SOFTWARE	Straumann USA	2013-06-28	102	0
K130808	STRAUMANN HEALING ABUTMENTS, HEALING CAPS, CLOSURE SCREWS	Straumann USA	2013-06-28	95	0
K122855	TL 04.1MM RN,S, SLACTIVE TIZR 6, 8, 10, 12, 14, 16MM DENTAL	Straumann USA	2012-12-12	85	0
K121131	BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM	Straumann USA	2012-06-06	54	1
K113606	NNC GOLD ABUTMENT FOR BRIDGES	Straumann USA	2012-01-27	52	0
K113410	NNC SOLID ABUTMENT NNC TEMPORARY COPING FOR COLID ABUTMENT N	Straumann USA	2012-01-13	56	0
K113283	NNC CEMENTABLE ABUTMENT STRAIGHT,15 DEGREE ANGLE, TYPE A ,15	Straumann USA	2011-12-28	51	0
K112280	STRAUMANN CARES SCREW-RETAINED BRIDGE TITANIUM, STRAUMANN CA	Straumann USA	2011-11-16	99	0
K111357	STRAUMANN NARROW NECK CROSSFIT (NNC) 03.3MM DENTAL IMPLANT S	Straumann USA	2011-10-03	140	0
K111724	STRAUMANN TIBRUSH	Straumann USA	2011-09-12	84	0
K110580	NARROW CONNECTION STRAUMANN ANATOMIC IPS E.MAX ABUTMENTS	Straumann USA	2011-08-12	164	0
K093027	STRAUMANN RC TEMPORARY ABUTMENTS	Straumann USA	2010-02-12	136	0
K083550	STRAUMANN DENTAL IMPLANT SYSTEM	Straumann USA	2009-02-26	87	0
K082532	STRAUMANN GUIDED INSTRUMENTS	Straumann USA	2008-10-21	49	0
K080286	CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTIVE CAPS	Straumann USA	2008-03-07	32	0
K073628	SYNOCTA ABUTMENTS	Straumann USA	2008-01-22	27	0
K071888	STRAUMANN P.004 RC GOLD ABUTMENT FOR BRIDGES	Straumann USA	2007-10-15	98	0
K072151	P.004 RC CARES TITANIUM AND CERAMIC ABUTMENTS	Straumann USA	2007-09-11	39	1
K071585	P.004 HEALING ABUTMENTS AND CLOSURE SCREWS	Straumann USA	2007-07-11	30	1
K063789	WN SYNOCTA GOLD ABUTMENT	Straumann USA	2007-05-10	140	0
K061277	STRAUMANN COMPUTER AIDED RESTORATION SERVICE (C.A.R.E.S.) CE	Straumann USA	2007-04-12	339	0
K063812	STRAUMANN PREFGEL	Straumann USA	2007-01-12	21	0
K060958	STRAUMANN NARROW NECK IMPLANTS	Straumann USA	2006-08-24	139	0
K052272	STRAUMANN COMPUTER AIDED RESTORATION SERVICE	Straumann USA	2006-01-03	134	0
K033243	ITI SYNOCTA MESO ABUTMENTS	Straumann USA	2003-10-20	13	0
K032498	DENTAL IMPLANT COPING (PROSTHETIC ACCESSORIES TO THE ITI DEN	Straumann USA	2003-08-27	14	0
K031055	ITI DENTAL IMPLANT SYSTEM	Straumann USA	2003-07-07	95	0
K030007	ITI DENTAL IMPLANT SYSTEM	Straumann USA	2003-03-31	89	0
K022859	ABUTMENT AND PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLAN	Straumann USA	2002-09-19	22	0
K012757	ITI DENTAL IMPLANT SYSTEM	Straumann USA	2001-08-22	5	0
K010291	ITI DENTAL IMPLANT SYSTEM	Straumann USA	2001-05-10	99	0
K002374	ITI DENTAL IMPLANT SYSTEM MONOTYPE IMPLANT	Straumann USA	2000-11-01	89	0
K994119	SYNOCTA ANGLED ABUTMENTS	Straumann USA	2000-03-17	102	0
K990342	SYNOCTA PROSTHETICS	Straumann USA	1999-07-20	166	0
K984104	ITI DENTAL IMPLANT SYSTEM	Straumann USA	1999-05-13	177	1
K990458	STRAUMANN EXTRAORAL IMPLANT SYSTEM	Straumann USA	1999-04-16	63	0
K982509	ORTHO IMPLANT AND ACCESSORIES	Straumann USA	1998-09-30	72	0
K973353	BONDING BASE	Straumann USA	1997-12-02	88	0
K971578	ENDOSSEOUS DENTAL IMPLANT	Straumann USA	1997-06-30	61	0
K962647	ANGLED ABUTMENT	Straumann USA	1996-10-07	91	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