Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

American Dental Products, Inc. · Predicate Candidate Screening

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

40 daysmedian FDA review time

83 days90th percentile

23clearances measured

K-number	Device	Applicant	Decided	Review days
K093014	AMERICAN DENTAL PRODUCTS SE BONDEASY	American Dental Products, Inc.	2010-04-16	199
K994368	AMERICAN DENTAL PRODUCTS CARIES-DETECTOR PLUS	American Dental Products, Inc.	2000-03-14	78
K991099	AMERICAN DENTAL PRODUCTS ETCH-DETECT	American Dental Products, Inc.	1999-06-10	70
K973185	AMERICAN DENTAL PRODUCTS HB-35 DESENSITIZER WITH FLUORIDE	American Dental Products, Inc.	1997-11-14	81
K964133	AMERICAN DENTAL PRODUCTS HG 35 DESENSITIZER WITH FLUORIDE	American Dental Products, Inc.	1997-01-09	86
K954637	AMERICAN DENTAL PRODUCTS TISSUE CONDITIONER & TEMPORARY RELI	American Dental Products, Inc.	1995-12-28	83
K954876	AMERICAN DENTAL PRODUCTS ROOT CANAL SEALER, WACH'S FORMULA	American Dental Products, Inc.	1995-11-15	22
K954133	AMERICAN DENTAL PRODUCTS WETTING AGENT & DESENSITIZER	American Dental Products, Inc.	1995-10-30	59
K954405	AMERICAN DENTAL PRODDUCTS LIGHT ACTIVATED COMPOSITE RESIN CO	American Dental Products, Inc.	1995-10-30	40
K954406	AMERICAN DENTAL PRODUCTS COMPOSITE RESIN CORE PASTE WITH FLU	American Dental Products, Inc.	1995-10-30	40
K954407	AMERICAN DENTAL PRODUCTS WHITE COMPOSITE RESIN CORE PASTE WI	American Dental Products, Inc.	1995-10-30	40
K954408	AMERICAN DENTAL PRODUCTS LIGHT ACTIVATED COMPOSITE RESIN COR	American Dental Products, Inc.	1995-10-30	40
K954701	AMERICAN DENTAL PRODUCTS PIT & FISSUE SEALANT LIGHT CURING	American Dental Products, Inc.	1995-10-30	18
K954373	AMERICAN DENTAL PRODUCTS PASTE-PRIMER ADHESIVE ORTHODONTIC B	American Dental Products, Inc.	1995-10-19	30
K954374	AMERICAN DENTAL PRODUCTS ORTHODONTIC ADHESIVE, TWO PASTE BON	American Dental Products, Inc.	1995-10-19	30
K954372	AMERICAN DENTAL PRODUCTS TWO PASTE ADHESIVE ORTHODONTIC BOND	American Dental Products, Inc.	1995-10-17	28
K954461	AMERICAN DENTAL PRODUCTS CORE BUILDUP PASTE	American Dental Products, Inc.	1995-10-16	21
K954244	AMERICAN DENTAL PRODUCTS LIGHT ACTIVATED ORTHODONTIC ADHESIV	American Dental Products, Inc.	1995-10-12	31
K954333	AMERICAN DENTAL PRODUCTS ORTHODONTIC ADHESIVE W/ONE STEP BON	American Dental Products, Inc.	1995-10-12	24
K954223	AMERICAN DENTAL PRODUCTS ALGINATE FLAVORING	American Dental Products, Inc.	1995-09-29	18
K951427	AMERICAN DENTAL PRODUCTS (ADP), COMPOSITE RESTORATIVE MATERI	American Dental Products, Inc.	1995-05-15	49
K951426	AMERICAN DENTAL PRODUCTS (ADP), VISIBLE LIGHT CURE COMPOSITE	American Dental Products, Inc.	1995-05-12	45
K950512	AMERICAN DENTAL PRODUCTS (ADP), FLUORIDE RELEASING GLASS ION	American Dental Products, Inc.	1995-03-07	29

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