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

Cdb Corporation — Predicate Candidate Screening

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

175 daysmedian FDA review time

199 days90th percentile

6clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K212173	HDH Treatment Planning System	Cdb Corporation	2022-01-25	197	0
K210613	HIT Clear Aligner	Cdb Corporation	2021-06-04	95	0
K191823	Clear-Aligners	Cdb Corporation	2019-12-20	165	0
K160957	CDB Self Ligating Bracket 8F	Cdb Corporation	2016-09-27	175	0
K091702	CDB FLIP-SIDE-CLIP BRACKET	Cdb Corporation	2009-08-07	58	0
K080906	CDB CLIP	Cdb Corporation	2008-10-17	199	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