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

Biomet 3i — Predicate Candidate Screening

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

134 daysmedian FDA review time

259 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K183138	Certain BellaTek Express and BellaTek Flex Abutments	Biomet 3i	2019-07-02	231	0
K173374	TSV BellaTek Encode Healing Abutments	Biomet 3i	2017-12-13	47	0
K170013	Eztetic BellaTek Encode Healing Abutments	Biomet 3i	2017-09-21	261	0
K150571	3i T3 Short Implants	Biomet 3i	2015-11-20	259	0
K133049	3I T3(R) EXTERNAL HEX DENTAL IMPLANTS	Biomet 3i	2014-01-08	103	0
K130949	CP4 OSSEOTITE CERTAIN DENTAL IMPLANTS	Biomet 3i	2013-07-30	116	1
K130310	CERTAIN BELLATEK PROVISIONAL ABUTMENTS	Biomet 3i	2013-06-21	134	0
K122300	T3 DENTAL IMPLANT	Biomet 3i	2013-01-30	183	3
K120776	ABUTMENT FOR COMPETITIVE IMPLANT NOBEL ACTIVE CONNECTION	Biomet 3i	2012-09-11	181	0
K112730	ABUTMENT FOR COMPETITIVE IMPLANT STRAUMANN BONE LEVEL CONNEC	Biomet 3i	2012-01-13	115	2
K110449	ENDOBON XENOGRAFT GRANULES	Biomet 3i	2011-05-13	86	1
K070147	INTERGRO ORAL	Biomet 3i	2007-05-14	118	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