Union Broach, Div. Moyco Industries, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Union Broach, Div. Moyco Industries, Inc.” (first 1982, latest 1996), across 11 product codes in 2 review panels. Median 510(k) review time under this name: 48 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EKS | File, Pulp Canal, Endodontic | 4 | 4 |
| CAH | Filter, Bacterial, Breathing-Circuit | 1 | 1 |
| EAT | Tester, Pulp | 1 | 1 |
| EAX | Mirror, Mouth | 1 | 1 |
| EEG | Heat Source For Bleaching Teeth | 1 | 1 |
| EKM | Gutta-Percha | 1 | 1 |
| EKP | Reamer, Pulp Canal, Endodontic | 1 | 1 |
| EKW | Broach, Endodontic | 1 | 1 |
| EMA | Cement, Dental | 1 | 1 |
| KJJ | Cleanser, Root Canal | 1 | 1 |
Plus 1 more product codes.
Review panels
- Dental (12)
- General Hospital (1)
Most recent Union Broach, Div. Moyco Industries, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K962733 | CYBER-FIL ALKENOATE CEMENT MULTI-PURPOSE KIT (23900/23905/23910/23915/23920) | EMA | 1996-10-11 | 88 |
| K950365 | MOYCO-EDTA | KJJ | 1995-04-27 | 86 |
| K941574 | RETRO MIRROR | EAX | 1994-05-18 | 48 |
| K940260 | THERMAL PULP TESTER | EAT | 1994-03-07 | 45 |
| K935542 | NICKEL-TITANIUM K-TYPE FILE | EKS | 1994-01-03 | 48 |
| K931742 | INJECT-R FILL | EKM | 1993-05-27 | 50 |
| K923661 | QUADRASORB FILTER | CAH | 1992-10-20 | 90 |
| K895174 | UNION BROACH BLEACHING LIGHT | EEG | 1990-04-13 | 249 |
| K855136 | FLEXOR FLEXIBLE ROANE TIP ENDODONTIC FILE | EKS | 1986-03-06 | 73 |
| K852474 | UNION BROACH BLEACHING LIGHT | — | 1985-07-01 | 20 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Union Broach, Div. Moyco Industries, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Union Carbide Corp. (69 510(k)s)
- Union Industrial Co., Ltd. (3 510(k)s)
- Union Branch (2 510(k)s)
- Union Medical Engeneering Co., Ltd. (2 510(k)s)
- Union Rubber Gloves Co., Ltd. (2 510(k)s)
- Union Surgical, LLC (2 510(k)s)
- Union Dental S.A. (1 510(k)s)
- Union Dental S.A./Unidesa.Odi (1 510(k)s)
- Union License Ent. Co., Ltd. (1 510(k)s)
- Union Medical Shenzhen Co., Ltd. (1 510(k)s)
- Union Medical USA (1 510(k)s)
- Union Medico Aps (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Union Broach, Div. Moyco Industries, Inc.?
FDA lists 14 510(k) clearances under the applicant name “Union Broach, Div. Moyco Industries, Inc.” (first 1982, latest 1996), across 11 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Union Broach, Div. Moyco Industries, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Union Broach, Div. Moyco Industries, Inc. is 48 days.
Which FDA product codes appear under Union Broach, Div. Moyco Industries, Inc.?
The most frequent FDA product codes under this applicant name are EKS (File, Pulp Canal, Endodontic, 4); CAH (Filter, Bacterial, Breathing-Circuit, 1); EAT (Tester, Pulp, 1).
Next steps
- See all 14 Union Broach, Div. Moyco Industries, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EKS, Union Broach, Div. Moyco Industries, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.