Atlas FDA

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

Health-Dent Intl., Inc. · Predicate Candidate Screening

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

31 daysmedian FDA review time
189 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K972198DENT-TEMP ACRYLICHealth-Dent Intl., Inc.1997-12-171890
K953405HEMA-BENZHealth-Dent Intl., Inc.1995-09-27690
K951220HEMA-GLUHealth-Dent Intl., Inc.1995-05-12530
K951381VILAHealth-Dent Intl., Inc.1995-04-27310
K951380VILA PCHealth-Dent Intl., Inc.1995-04-27310
K951235GIROCHealth-Dent Intl., Inc.1995-04-20310
K951236PRO-LOCKHealth-Dent Intl., Inc.1995-04-18290
K951237ALGI-BANDHealth-Dent Intl., Inc.1995-04-10210

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