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

Ortho Source — Predicate Candidate Screening

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

63 daysmedian FDA review time

366 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days
K913853	FISSURE SEALER	Ortho Source	1992-08-27	366
K913854	ORTHO LIGHT CURE	Ortho Source	1992-01-14	140
K913519	SUMO GLASS IONOMER CEMENT	Ortho Source	1991-11-19	104
K884949	VISIBLE LIGHT CURE CALCIUM HYDROXIDE LINER	Ortho Source	1989-02-23	90
K884575	MAXIBOND	Ortho Source	1989-01-03	63
K861118	ORTHOJOIN, ORTHODONTIC ADHESIVE	Ortho Source	1986-05-02	38
K861258	PERMABAND (ORTHODONTIC ADHESIVE)	Ortho Source	1986-04-17	14
K861245	ORTHOSOURCE ETCH SYSTEMS	Ortho Source	1986-04-11	9
K860959	DEPENDABOND	Ortho Source	1986-03-25	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