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

Ceramed Corp. — Predicate Candidate Screening

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

88 daysmedian FDA review time

179 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days
K962838	PERMARIDGE SYRINGE	Ceramed Corp.	1996-08-20	29
K962786	OSTEOGRAF STAINLESS STEEL SYRING	Ceramed Corp.	1996-08-01	15
K960348	OSTEOGRAF/N-300 HYDROXYLAPATITE	Ceramed Corp.	1996-04-22	88
K960368	OSTEOGRAFT/N-700 HYDROXYLAPTITE	Ceramed Corp.	1996-04-18	84
K960353	OSTEOGRAF/LD-300 HYDROXYLAPATITE	Ceramed Corp.	1996-04-18	84
K960361	PERMAMESH-D HYDROXYLAPATITE MATRIX	Ceramed Corp.	1996-04-15	81
K960362	PERMAMESH HYDROXYLAPATITE MATRIX	Ceramed Corp.	1996-03-20	55
K960354	PERMAMESH-D HYDROXYLAPATITE MATRIX	Ceramed Corp.	1996-03-20	55
K960349	PERMARIDGE HYDROXYLAPATITE MATRIX	Ceramed Corp.	1996-03-13	48
K954631	OSTEOGRAF/N-BLOCCK HYDROXYLAPATITE	Ceramed Corp.	1996-01-02	88
K942946	OSTEOGRAF/D-100 HYDROXYLAPATITE	Ceramed Corp.	1994-10-05	104
K942212	OSTEOGRAF/LD-300 HYDROXYLAPATITE	Ceramed Corp.	1994-08-23	109
K921468	PERMAMESH HYDROXYLAPATITE MATRIX	Ceramed Corp.	1992-08-21	147
K921469	OSTEOGRAF/N-700 NATURAL HYDROXYLAPATITE 18-40 MESH	Ceramed Corp.	1992-06-25	90
K902295	OSTEOGRAF/N NATURAL HYDROXYLAPATITE, 40-60 MESH	Ceramed Corp.	1990-12-11	203
K891173	OSTEOGRAF/P PERIODONTAL HYDROXYLAPATITE, 40-60	Ceramed Corp.	1989-09-01	179

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