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

EAY · Predicate Candidate Screening

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

53 daysmedian FDA review time

74 days90th percentile

18clearances measured

K-number	Device	Applicant	Decided	Review days
K953191	MODEL A15-101	Beaverstate Dental, Inc.	1995-09-05	74
K953192	MODEL A15-103	Beaverstate Dental, Inc.	1995-09-05	74
K935718	JEDENTAL VLC DENTAL CURING LIGHT	Jedental Co., Inc.	1994-01-26	57
K871816	STRYKERSCOPE TM/ORTHOSCOPE TM/STRYKER MINISCOPE TM	Stryker Corp.	1987-08-03	84
K831976	POWER OPTIC	Ritter Co.	1983-08-12	53
K831824	DENTAL ELECTRONIC/S.B.R TRADING BU HAND	Silverman'S	1983-08-11	65
K820907	DENTISCOPE	Chayes Virginia, Inc.	1982-05-05	34
K812605	FIBER OPTIC LIGHT SOURCE I	Venture Technology, Inc.	1981-10-02	17
K802684	HELIOMAT	Vivadent (Usa), Inc.	1980-11-24	27
K802716	DEN-MAT FIBER OPTIC HALOGEN LIGHT	Den-Mat Corp.	1980-11-12	12
K801591	FIBER OPTIC ILLUMINATOR	Lares Manufacturing Co., Inc.	1980-07-21	10
K801592	FIBER OPTIC HOSE	Lares Manufacturing Co., Inc.	1980-07-21	10
K791771	ORALUMINATOR III AUTO-LIGHT	Midwest	1979-11-20	74
K791733	LIGHT-PAK	Midwest	1979-10-23	56
K781878	LIGHT, INSIDE	Midwest	1978-12-29	53
K761331	OPUS I OPTION - FIBER OPTIC L SYSTEM	Syntex Corp.	1977-01-03	7
K760795	FIBER OPTICS DENTAL HOSE W/INTEGRAL L.C.	Midwest	1976-10-20	12
K760796	ORALUMINATOR III - LIGHT SOURCE FOR F.O.	Midwest	1976-10-20	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