Atlas FDA

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

Micerium S.P.A. · Predicate Candidate Screening

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

87 daysmedian FDA review time
135 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K103474ENA TEMP AND ENAMEL PLUS TEMP (TWO DIFFERENT PROPRIETARY NAMMicerium S.P.A.2011-02-07730
K072978TENDER ORTHO BOND-ENA BOND-ENA ETCHMicerium S.P.A.2008-01-17870
K063170TENDER FIBERMicerium S.P.A.2007-01-12860
K062355ENA CEMMicerium S.P.A.2006-12-271350
K062367MINISCREWS ANCHORING SYSTEM, M.A.S.Micerium S.P.A.2006-12-081160
K062906ENA HFO COMPOSITE SYSTEMMicerium S.P.A.2006-11-17510

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