Star Dental Mfg. Co.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Star Dental Mfg. Co.” (first 1977, latest 1991), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 26 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 |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 1 | 1 |
| ECX | Cylinder, Compressed Gas, And Valve | 1 | 1 |
| EFB | Handpiece, Air-Powered, Dental | 1 | 1 |
| ELB | Scaler, Rotary | 1 | 1 |
| EMA | Cement, Dental | 1 | 1 |
Review panels
- Dental (4)
- Anesthesiology (1)
Most recent Star Dental Mfg. Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K905155 | HIGH SPEED CEREAMIC BEARING TURBINE HANDPIECES | EFB | 1991-02-13 | 90 |
| K782007 | ROTARY SCALER | ELB | 1979-01-03 | 33 |
| K781281 | CEMENT, DENTAL/CAVITY LINER | EMA | 1978-08-21 | 26 |
| K771247 | CORE MATERIAL | EBF | 1977-07-15 | 4 |
| K771246 | ALARM SYS FOR NITROUS OXIDE SYS. | ECX | 1977-07-15 | 4 |
Recalls
openFDA lists no recalls under a recalling firm named Star Dental Mfg. Co..
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.
- Star Medical Technologies, Inc. (3 510(k)s)
- Star Refining Precious Metals South Africa (2 510(k)s)
- Star Technologies, Inc. (2 510(k)s)
- Star Dentech Korea., Corp (1 510(k)s)
- Star Instrument Co. (1 510(k)s)
- Star Investment and Trade Joint Stock Company (1 510(k)s)
- Star Light Ent. Corp. (1 510(k)s)
- Star Mountain Medical, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Star Dental Mfg. Co.?
FDA lists 5 510(k) clearances under the applicant name “Star Dental Mfg. Co.” (first 1977, latest 1991), across 5 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 Star Dental Mfg. Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Star Dental Mfg. Co. is 26 days.
Which FDA product codes appear under Star Dental Mfg. Co.?
The most frequent FDA product codes under this applicant name are EBF (Material, Tooth Shade, Resin, 1); ECX (Cylinder, Compressed Gas, And Valve, 1); EFB (Handpiece, Air-Powered, Dental, 1).
Next steps
- See all 5 Star Dental Mfg. Co. clearances with predicates and recalls
- Run predicate analysis for product code EBF, Star Dental Mfg. Co.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.