Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

United Dental Mfg., Inc. · Predicate Candidate Screening

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

21 daysmedian FDA review time
162 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K843017ABSORBENT ENDODONTIC POINTUnited Dental Mfg., Inc.1985-01-091620
K823684FILE TYPE K ENDODONTICUnited Dental Mfg., Inc.1982-12-28210
K823685FILE TYPE H (HEDSTROEM) ENDODONTICUnited Dental Mfg., Inc.1982-12-28210
K823686REAMER TYPE K ENDODONTICUnited Dental Mfg., Inc.1982-12-28210
K812886ENDODONTIC PAPER POINTSUnited Dental Mfg., Inc.1981-11-16330

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