Atlas FDA

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

Novamin Technology, Inc. — Predicate Candidate Screening

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

57 daysmedian FDA review time
155 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K080228ORALIEF OTC TOOTHPASTE FOR SENSITIVE TEETHNovamin Technology, Inc.2008-03-27570
K071267PERIOSRP TOOTH ROOT CONDITIONER WITH NOVAMINNovamin Technology, Inc.2007-05-18110
K061359DENSHIELD TREATMENT FOR SENSITIVE TEETHNovamin Technology, Inc.2006-10-181550
K040858ORALIEF THERAPY FOR SENSITIVE TEETHNovamin Technology, Inc.2004-09-021530
K041371BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMINNovamin Technology, Inc.2004-08-23910
K040473ORAVIVE TOOTH REVITALIZING PASTENovamin Technology, Inc.2004-03-10150
K033295BUTLER NUCARE ROOT CONDITIONER WITH NOVAMINNovamin Technology, Inc.2003-10-28140

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