United Dental Mfg., Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “United Dental Mfg., Inc.” (first 1981, latest 1985), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 21 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 |
|---|---|---|---|
| EKN | Point, Paper, Endodontic | 2 | 2 |
| EKS | File, Pulp Canal, Endodontic | 2 | 2 |
| EKP | Reamer, Pulp Canal, Endodontic | 1 | 1 |
Review panels
- Dental (5)
Most recent United Dental Mfg., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K843017 | ABSORBENT ENDODONTIC POINT | EKN | 1985-01-09 | 162 |
| K823686 | REAMER TYPE K ENDODONTIC | EKP | 1982-12-28 | 21 |
| K823685 | FILE TYPE H (HEDSTROEM) ENDODONTIC | EKS | 1982-12-28 | 21 |
| K823684 | FILE TYPE K ENDODONTIC | EKS | 1982-12-28 | 21 |
| K812886 | ENDODONTIC PAPER POINTS | EKN | 1981-11-16 | 33 |
Recalls
openFDA lists no recalls under a recalling firm named United Dental Mfg., 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.
- United States Surgical, A Division of Tyco Healthc (218 510(k)s)
- United States Endoscopy Group, Inc. (94 510(k)s)
- United Orthopedic Corporation (61 510(k)s)
- United Biotech, Inc. (22 510(k)s)
- United Consortium (15 510(k)s)
- United Diagnostics, Inc. (12 510(k)s)
- United Medical Industries Co. , Ltd. (10 510(k)s)
- United Surgical Corp. (7 510(k)s)
- United Pacific Co., Ltd. (6 510(k)s)
- United Medical Systems, Inc. (5 510(k)s)
- United Sonics, Inc. (5 510(k)s)
- United Medical (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under United Dental Mfg., Inc.?
FDA lists 5 510(k) clearances under the applicant name “United Dental Mfg., Inc.” (first 1981, latest 1985), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by United Dental Mfg., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name United Dental Mfg., Inc. is 21 days.
Which FDA product codes appear under United Dental Mfg., Inc.?
The most frequent FDA product codes under this applicant name are EKN (Point, Paper, Endodontic, 2); EKS (File, Pulp Canal, Endodontic, 2); EKP (Reamer, Pulp Canal, Endodontic, 1).
Next steps
- See all 5 United Dental Mfg., Inc. clearances with predicates and recalls
- Run predicate analysis for product code EKN, United Dental Mfg., 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.