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

Biomet 3i, Inc. — Predicate Candidate Screening

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

154 daysmedian FDA review time

276 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K111216	OSSEOTITE 2 DENTAL IMPLANTS	Biomet 3i, Inc.	2011-11-18	200	0
K110565	ABUTMENTS FOR COMPETITIVE IMPLANT SYSTEMS-NOBEL REPLACE	Biomet 3i, Inc.	2011-09-01	185	0
K100724	OSSEOTITE II MODEL XIFOSSXXX	Biomet 3i, Inc.	2011-04-01	382	5
K101607	BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS - ENCODE ABUTMEN	Biomet 3i, Inc.	2011-03-11	276	0
K101608	BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS-ENCODE ABUTMENTS	Biomet 3i, Inc.	2011-03-11	276	0
K102209	ENCODE PATIENT SPECIFIC ABUTMENT	Biomet 3i, Inc.	2010-12-03	120	0
K101582	CAM STRUCTSURE BARS	Biomet 3i, Inc.	2010-11-08	154	0
K092341	LOW PROFILE ABUTMENTS - INTERNAL AND EXTERNAL CONNECTION	Biomet 3i, Inc.	2009-11-30	118	3
K080864	CAM STRUCTSURE PRECISION MILLED BARS	Biomet 3i, Inc.	2008-07-21	115	0
K073345	CERTAIN CONTOURED MARGIN CERAMIC ABUTMENT	Biomet 3i, Inc.	2008-03-07	100	0
K072363	NANOTITE PREVAIL,CERTAIN,PARELLEL WALLED,TAPERED,EXTERNAL HE	Biomet 3i, Inc.	2008-01-31	161	0
K072642	BIOMET 3I DENTAL ABUTMENTS AND RESTORATIVE COMPONENTS	Biomet 3i, Inc.	2007-12-20	93	58
K071551	QUICKBRIDGE TM CYLINDER AND CAP	Biomet 3i, Inc.	2007-08-30	85	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