Atlas FDA

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

Advanced Healthcare , Ltd. · Predicate Candidate Screening

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

K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K024287FIXOBRIDGE 3-CEMENTAdvanced Healthcare , Ltd.2003-03-21880
K023981AHL GENERIC GLASS IONOMER LUTING CEMENTAdvanced Healthcare , Ltd.2003-01-31600
K020376AHL GENERIC GLASS IONOMER AESTHETIC RESTORATIVEAdvanced Healthcare , Ltd.2002-04-09640

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