Atlas FDA

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

Union Broach, Div. Moyco Industries, Inc. · Predicate Candidate Screening

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

48 daysmedian FDA review time
90 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K962733CYBER-FIL ALKENOATE CEMENT MULTI-PURPOSE KIT (23900/23905/23Union Broach, Div. Moyco Industries, Inc.1996-10-11880
K950365MOYCO-EDTAUnion Broach, Div. Moyco Industries, Inc.1995-04-27860
K941574RETRO MIRRORUnion Broach, Div. Moyco Industries, Inc.1994-05-18480
K940260THERMAL PULP TESTERUnion Broach, Div. Moyco Industries, Inc.1994-03-07450
K935542NICKEL-TITANIUM K-TYPE FILEUnion Broach, Div. Moyco Industries, Inc.1994-01-03480
K931742INJECT-R FILLUnion Broach, Div. Moyco Industries, Inc.1993-05-27500
K923661QUADRASORB FILTERUnion Broach, Div. Moyco Industries, Inc.1992-10-20900
K895174UNION BROACH BLEACHING LIGHTUnion Broach, Div. Moyco Industries, Inc.1990-04-132490
K855136FLEXOR FLEXIBLE ROANE TIP ENDODONTIC FILEUnion Broach, Div. Moyco Industries, Inc.1986-03-06730
K852474UNION BROACH BLEACHING LIGHTUnion Broach, Div. Moyco Industries, Inc.1985-07-01200
K823489ENDODONTIC BROACH-BARBED BROACHUnion Broach, Div. Moyco Industries, Inc.1982-12-15220
K822620ROOT CANAL REAMERS, TYPE KUnion Broach, Div. Moyco Industries, Inc.1982-09-28290
K822621ROOT CANAL FILES, TYPE KUnion Broach, Div. Moyco Industries, Inc.1982-09-28290
K822622ROOT CANAL FILES, TYPE H (HEDSTROMUnion Broach, Div. Moyco Industries, Inc.1982-09-28290

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