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

Collagen Corp. — Predicate Candidate Screening

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

82 daysmedian FDA review time

210 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K904671	QAR HANDPIECE	Collagen Corp.	1990-12-21	70	0
K904228	OSSEODENT DENTAL ATTACHMENTS (NON-ANGLED)	Collagen Corp.	1990-11-09	87	1
K901600	OSSEOTITE IRRIGATION UNIT	Collagen Corp.	1990-06-21	76	0
K900275	OSSEODENT DENTAL ATTACHMENT, IGLOO MAGNET	Collagen Corp.	1990-04-19	90	0
K895462	OSSEODENT DENTAL ATTACHMENTS	Collagen Corp.	1990-04-04	210	0
K895463	OSSEODENT(R) PRECISION DENTAL ATTACHMENTS	Collagen Corp.	1990-03-28	203	0
K894331	OSSEODENT SURGICAL KIT	Collagen Corp.	1989-10-04	82	0
K883322	DENTAL HAND INSTRUMENTS	Collagen Corp.	1988-08-26	21	0
K812617	VITROGEN TM 100	Collagen Corp.	1981-10-02	17	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