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

Thommen Medical AG — Predicate Candidate Screening

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

72 daysmedian FDA review time

186 days90th percentile

26clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K171795	Thommen Implant System	Thommen Medical AG	2017-09-29	105	0
K160244	VARIOunite	Thommen Medical AG	2016-06-02	122	0
K151984	Thommen Milling Abutment for CAD/CAM	Thommen Medical AG	2016-03-10	237	0
K121334	VARIOECO	Thommen Medical AG	2012-08-14	103	0
K111984	SPI VARIO ANGLED ABUTMENT	Thommen Medical AG	2011-11-10	121	0
K102804	SPI TITANIUM BASE FOR CAD/CAM	Thommen Medical AG	2011-04-20	205	0
K101798	SPI VARIOMULTI ANGLED ABUTMENT	Thommen Medical AG	2010-08-19	52	0
K093615	SPI DENTAL IMPLANT, ELEMENT	Thommen Medical AG	2010-03-04	101	0
K092248	SPI CUSTOMIZABLE GINGIVA FORMER	Thommen Medical AG	2009-09-25	59	0
K090154	SPI DENTAL IMPLANT INICELL	Thommen Medical AG	2009-07-27	186	0
K090153	SPI VARIOMULTI ANGLED ABUTMENT	Thommen Medical AG	2009-03-27	64	0
K072856	SPI VARIOMULTI ABUTMENT	Thommen Medical AG	2008-02-15	133	0
K072649	SPI SYSTEM DENTAL IMPLANTS	Thommen Medical AG	2007-12-06	78	0
K073141	SPI ART ABUTMENT	Thommen Medical AG	2007-12-05	28	0
K072933	SPI CONTACT PLATFORM O 4.0 MM	Thommen Medical AG	2007-11-15	30	0
K071453	SPI EASY 4.0 ABUTMENT	Thommen Medical AG	2007-09-19	117	0
K070290	SPI VECTODRILL CERAMIC DRILLS	Thommen Medical AG	2007-04-17	77	0
K070007	SPI ELEMENT PLATFORM O 4.0 MM	Thommen Medical AG	2007-01-10	7	0
K061807	SPI ART ABUTMENTS	Thommen Medical AG	2006-07-31	34	0
K051527	SPI EASY TEMPORARY CAP	Thommen Medical AG	2005-07-28	50	0
K051502	SPI DENTAL IMPLANT	Thommen Medical AG	2005-06-21	14	0
K034014	SPI CONTACT DENTAL IMPLANT	Thommen Medical AG	2004-03-05	72	0
K033346	SPI EASY DENTAL IMPLANT PROTECTIVE CAP	Thommen Medical AG	2003-11-03	14	0
K031747	SPI DENTAL IMPLANT ABUTMENTS	Thommen Medical AG	2003-07-02	27	0
K030689	SPI ELEMENT DENTAL IMPLANT O 3.5 MM	Thommen Medical AG	2003-03-26	21	0
K023645	SPI EASY DENTAL IMPLANT ABUTMENT	Thommen Medical AG	2002-11-13	14	1

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