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

DZN — Predicate Candidate Screening

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

44 daysmedian FDA review time

304 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days
K111465	COMPOTHIXO	Kerrhawe SA	2012-07-25	426
K071858	DENTAL MATRIX BAND	Fly Cast Technologies, Inc.	2007-08-31	57
K901919	CONTACT MOLAR BANDS AND CONTOUR STRIPS	Ivoclar North America, Inc.	1990-06-22	57
K861581	CENTRIX PCR MOLAR MATRIX FORMS (BANDS)	Centrix, Inc.	1986-05-12	13
K844324	TIGER BAND	World Wide Outdoor Marketing	1984-12-03	26
K840984	INTERDENTAL WEDGES	Healthco, Inc.	1984-04-13	38
K822094	DENTAL MATRIX BAND	Dentsply Intl.	1982-08-16	31
K821444	COLORED WEDGE USED TO SEPARATE TEETH	Moyco Industries, Inc.	1982-06-14	31
K801142	PALODENT MATRICES & BITINE RINGS	Alvin Meyer, D.D.S.	1980-08-07	86
K801530	COREFORM MOLDS	Sybron Corp.	1980-07-28	26
K790555	HEMO-WEDGE	Parker Laboratories, Inc.	1980-01-17	304
K790599	RUWA MATRIX STRIPS	Howmedica Corp.	1979-05-21	56
K790600	HOWMEDICA STRIP CROWN	Howmedica Corp.	1979-05-21	56
K790633	ACCOR MATRIX	Accor, Inc.	1979-05-17	44
K772314	WEDGES, RETAINING, MATRIX	Den-Mat Corp.	1978-01-03	15
K772316	MATRIX STRIP, DEAD-SOFT	Den-Mat Corp.	1978-01-03	15

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