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

Unicep — Predicate Candidate Screening

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

158 daysmedian FDA review time

226 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days
K925163	MICODOSE CHLORHEXIPREP	Unicep	1993-05-27	226
K924824	MICRODOSE PIT AND FISSURE SEALANT-CLEAR OR WHITE	Unicep	1993-03-16	169
K924823	MICRODOSE SILANE	Unicep	1993-03-16	169
K925162	MICRODOSE DENTIN CONDITIONER	Unicep	1993-03-16	154
K924821	MICRODOSE PORCELAIN ETCHANT	Unicep	1993-03-16	169
K924822	MICRODOSE ENAMEL ETCHANT	Unicep	1993-03-05	158
K924825	MICRODOSE RC-EZ	Unicep	1993-03-05	158
K924826	MICRODOSE TOTAL ETCHANT	Unicep	1993-03-05	158
K924827	MICRODOSE POTASSIUM OXYLATE	Unicep	1993-03-05	158

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