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

Straumann USA, LLC — Predicate Candidate Screening

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

135 daysmedian FDA review time

218 days90th percentile

24clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K241575	Straumann® Anatomic Healing Abutments XC (AHA)	Straumann USA, LLC	2024-11-11	161	1
K203753	Straumann Surgical Cassettes	Straumann USA, LLC	2021-07-29	218	0
K202942	Straumann 4 mm Short Implants	Straumann USA, LLC	2021-02-08	131	0
K192401	Straumann Screw-Retained Abutments	Straumann USA, LLC	2020-04-06	216	0
K190662	MRI Compatibility for Existing Straumann Dental Implant Syst	Straumann USA, LLC	2019-06-17	94	0
K171784	Straumann Dental Implant System	Straumann USA, LLC	2018-01-19	218	0
K162890	BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap a	Straumann USA, LLC	2017-03-08	142	0
K151590	Straumann RN Gold Abutment for Bridge	Straumann USA, LLC	2016-03-04	266	0
K150899	Straumann CARES Titanium Alloy (TAN) Abutment	Straumann USA, LLC	2015-09-16	166	0
K151324	Straumann Variobase for CEREC	Straumann USA, LLC	2015-09-11	116	0
K151247	NC Straumann Screw Retained Abutments	Straumann USA, LLC	2015-08-10	91	0
K150814	Straumann Screw-Retained Abutment	Straumann USA, LLC	2015-08-10	136	0
K151157	NC Straumann Variobase Abutment for Bars/Bridges, RC Strauma	Straumann USA, LLC	2015-08-05	96	0
K150938	Straumann® Dental Implant System ¿ Roxolid® SLA Implants	Straumann USA, LLC	2015-07-24	108	0
K142890	Straumann Variobase Abutment NNC, Straumann Variobase Abutme	Straumann USA, LLC	2015-01-09	98	0
K140878	STRAUMANN BONE LEVEL TAPERED IMPLANT	Straumann USA, LLC	2014-08-20	135	2
K140737	STRAUMANN CARES SCREW RETAINED BARS/BRIDGE	Straumann USA, LLC	2014-08-14	143	0
K141871	Straumann Bone Level NC Angled Screw Retained Abutments	Straumann USA, LLC	2014-08-07	27	0
K133421	STRAUMANN MAGELLAN(TM) ABUTMENT,PROTECTIVE CAP,TITANIUM COPI	Straumann USA, LLC	2014-04-17	160	0
K132219	STRAUMANN(R) VARIOBASE(TM) ABUTMENT NNC, STRAUMANN(R) VARIOB	Straumann USA, LLC	2014-02-21	219	0
K132844	STRAUMANN CARES BONE LEVEL SCREW RETAINED BARS, STRAUMANN CA	Straumann USA, LLC	2014-01-15	126	0
K130222	STRAUMANN DENTAL IMPLANT SYSTEM	Straumann USA, LLC	2013-04-29	90	0
K123784	STRAUMANN DENTAL IMPLANT SYSTEM	Straumann USA, LLC	2013-04-10	121	0
K122192	NC TEMPORARY ABUTMENT, CAD-TEMP, PMMA RC TEMPORARY ABUTMENT,	Straumann USA, LLC	2012-11-02	101	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