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

Den-Mat Corp. — Predicate Candidate Screening

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

41 daysmedian FDA review time

181 days90th percentile

29clearances measured

K-number	Device	Applicant	Decided	Review days
K983106	1ST IMPRESSION	Den-Mat Corp.	1999-02-09	158
K895731	DEN-MAT CERINATE PORCELAIN	Den-Mat Corp.	1990-08-03	311
K895269	DEN-MAT LAMI-QUICK	Den-Mat Corp.	1990-02-22	183
K881918	LIGHT-CURED ZIONOMER CEMENT	Den-Mat Corp.	1988-07-15	67
K875351	DEN-MAT PORETCH (PORCELAIN ETCHANT)	Den-Mat Corp.	1988-03-18	78
K872510	DEN-MAT TENURE	Den-Mat Corp.	1987-08-24	61
K870130	DEN-MAT SECURE ANTI-ROTATIONAL POST-CORE SYSTEM	Den-Mat Corp.	1987-02-19	38
K864346	REMBRANDT PORCELAIN TINTING KIT	Den-Mat Corp.	1987-01-07	64
K862449	DEN-MAT DENTIN LINK	Den-Mat Corp.	1986-07-22	25
K860971	DEN-MAT GOLD LINK (FORMERLY DEN-MAT METAL OPAQUER)	Den-Mat Corp.	1986-03-25	21
K852630	DEN-MAT PAINT-ON RUBBER DAM	Den-Mat Corp.	1985-12-18	181
K852196	ZIONOMER CEMENT	Den-Mat Corp.	1985-06-20	31
K841111	REMBRANDT SHADE MODIFICATION KIT	Den-Mat Corp.	1984-03-30	15
K832497	CAVITY CLEANSER	Den-Mat Corp.	1983-10-04	69
K802716	DEN-MAT FIBER OPTIC HALOGEN LIGHT	Den-Mat Corp.	1980-11-12	12
K801225	DEN-MAT POLISHING PASTE	Den-Mat Corp.	1980-06-17	26
K801216	DEN-MAT DENTIN BONDING AGENT	Den-Mat Corp.	1980-05-28	7
K791925	DEN-MAT 4-MINUTE DENTURE CLEANER	Den-Mat Corp.	1979-10-26	29
K791223	DEN-MAT DENTAL FLOSSER	Den-Mat Corp.	1979-10-09	98
K790589	DENTURE-TIGHT	Den-Mat Corp.	1979-08-10	136
K790096	SALIVAN PARAEIGHT TOUGHNESS	Den-Mat Corp.	1979-02-26	41
K790097	SALIVAN & SALIVAN BROWN	Den-Mat Corp.	1979-02-26	41
K781244	TEMP. CROWN MSTERIAL FOR TEETH	Den-Mat Corp.	1978-08-31	43
K771974	SOLVENEX I-0	Den-Mat Corp.	1978-01-12	87
K772314	WEDGES, RETAINING, MATRIX	Den-Mat Corp.	1978-01-03	15
K772315	KWIKAP	Den-Mat Corp.	1978-01-03	15
K772316	MATRIX STRIP, DEAD-SOFT	Den-Mat Corp.	1978-01-03	15
K771973	GINGITRACT	Den-Mat Corp.	1977-11-07	21
K771214	SUPERFINE DIAMONDS	Den-Mat Corp.	1977-07-15	10

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