Atlas FDA

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

NOF — Predicate Candidate Screening

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

99 daysmedian FDA review time
210 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K141611LYTHOS DIGITAL IMPRESSION SYSTEMOrmco Corp.2014-12-051720
K122065DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USEOrmco Corp.2013-02-082100
K1224673M TRUE DEFINITION SCANNER3M Company2012-11-20990
K0819613M UNITEK LAVA CHAIRSIDE ORAL SCANNERBrontes Technologies2008-09-05580
K0731993M ESPE LAVA CHAIRSIDE ORAL SCANNERBrontes Technologies2007-12-21380

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