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

EIG · Predicate Candidate Screening

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

57 daysmedian FDA review time

95 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days
K971284	OPALDAM	Ultradent Products, Inc.	1997-06-03	57
K854711	FIBRELIGHT ILLUMINATING ORAL RETRACTORS	Downs Surgical , Ltd.	1986-02-25	95
K832366	ZOLLER BURNED LIP CONFORMER	Universal Prosthetics, Inc.	1983-09-26	70
K821784	BEACH GINGIVAL RETRACTION INSTR. TYPE B	Pacific Dental Corp.	1982-07-06	19
K771973	GINGITRACT	Den-Mat Corp.	1977-11-07	21
K771399	LIP & CHEEK RETRACTOR	L.D. Caulk Co.	1977-08-26	28
K761024	RACESTYPTINE RINGS	Septodont, Inc.	1976-11-19	65
K760657	RACESTYPTINE CORD	Septodont, Inc.	1976-09-27	12

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