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

Rite-Dent Manufacturing Corp. — Predicate Candidate Screening

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

73 daysmedian FDA review time

82 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K020050	ENAMEL BONDING SYSTEM	Rite-Dent Manufacturing Corp.	2002-02-14	38	0
K011822	PIT AND FISSURE CHEMICAL CURING SEALANT	Rite-Dent Manufacturing Corp.	2001-08-07	57	0
K011453	TOOTH SHADE RESIN MATERIAL	Rite-Dent Manufacturing Corp.	2001-07-23	73	0
K010255	CAVITY VARNISH	Rite-Dent Manufacturing Corp.	2001-04-20	81	0
K010240	POLYCARBOXYLATE (PCA) CEMENT	Rite-Dent Manufacturing Corp.	2001-03-27	61	0
K003427	ZINC PHOSPHATE CEMENT	Rite-Dent Manufacturing Corp.	2001-01-24	82	0
K003426	ALGINATE IMPRESSION MATERIAL	Rite-Dent Manufacturing Corp.	2001-01-23	81	1

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