Solar Dental Co., Inc.: FDA clearances and approvals
Solar Dental Co., Inc. has 6 FDA 510(k) clearances (first 1983, latest 1987), across 6 product codes in 1 review panel. Median 510(k) review time: 44 days.
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 |
|---|---|---|---|
| EBG | Crown And Bridge, Temporary, Resin | 1 | 1 |
| EBH | Material, Impression Tray, Resin | 1 | 1 |
| EIC | Syringe, Periodontic, Endodontic, Irrigating | 1 | 1 |
| KOJ | Airbrush | 1 | 1 |
| KOQ | Adhesive, Denture, Carboxymethylcellulose Sodium (40-100&) | 1 | 1 |
Plus 1 more product codes.
Review panels
- Dental (5)
Most recent Solar Dental Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K871980 | D-23 DENTURE ADHESIVE | KOJ | 1987-06-05 | 14 |
| K861846 | HYDRON ROOT CANAL FILLING & MARK IV STARTER KIT | EIC | 1986-06-26 | 44 |
| K852926 | DENTOLOCK II DENTURE ADHESIVE CREAM | — | 1985-08-23 | 45 |
| K831294 | SOLARCRY/TEMPORARY CROWN & BRIDGE MAT | EBG | 1983-08-31 | 133 |
| K831293 | SOLARCRYL CUSTOM TRAY MATERIAL | EBH | 1983-07-26 | 97 |
| K831265 | DENTOLOCK DENTURE ADHESIVE CREAM | KOQ | 1983-05-09 | 21 |
Recalls
openFDA lists no recalls under a recalling firm named Solar Dental Co., Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Solar Dental Co., Inc. have?
Solar Dental Co., Inc. has 6 FDA 510(k) clearances (first 1983, latest 1987), across 6 product codes in 1 review panel.
How long does FDA take to clear Solar Dental Co., Inc.'s 510(k)s?
The median time from FDA receipt to decision across Solar Dental Co., Inc.'s cleared 510(k)s is 44 days.
What devices does Solar Dental Co., Inc. make?
Its most frequent FDA product codes are EBG (Crown And Bridge, Temporary, Resin, 1); EBH (Material, Impression Tray, Resin, 1); EIC (Syringe, Periodontic, Endodontic, Irrigating, 1).
Has Solar Dental Co., Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Solar Dental Co., Inc. Related entities may recall under other names.
Next steps
- See all 6 Solar Dental Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code EBG, Solar Dental Co., Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.