Prosthetic devices · 21 CFR 872 Subpart D
External Cleaning Solution
For use on dental restorations, external to the mouth, prior to insertion into the mouth.
- Companies listing it
- 1611 makers
- Brands and models
- 15
- 510(k) clearances
- 30 in five years
- FDA name
- External Cleaning Solution
510(k) clearances per year, 1976–2026
Companies that list PME
16 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Rizhao HuGe Biomaterials Company, Ltd. | China | Maker | HF-Etchant Hydrofluoric Acid Etching Gel | 13 | 2025 |
| Kuraray Noritake Dental, Inc. | Japan | Maker | KATANA Cleaner | 32 | 2025 |
| Inter-Med, Inc. | United States | Maker | ZrC | 7 | 2026 |
| Liaoning Upcera Co., Ltd | China | Maker | Ceramic Etchant (HF-5 and HF-9) | 10 | 2026 |
| Bisco, Inc. | United States | Maker | ZirClean | 88 | 2025 |
| Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | Türkiye | Maker | CERAXIDIN-C, Vayfic, PAMA Solution, Imisemme, Traysemme | 5 | 2022 |
| Prime Dental Manufacturing, Inc. | United States | Maker | Prime-Dent White Fluoride Varnish | 9 | 2012 |
| George Taub Products & Fusion Co., Inc. | United States | Maker | — | 2 | 1986 |
| Denali R & D Corporation | United States | Maker | Resolve | 2 | 2009 |
| Signor Seven International | Pakistan | Maker | Examination Kit, Mirror, Cotton plier, Explorer SKU 10-325Kit · Examination Kit; Mirror, Cotton plier, Explorer, 3/Pk. SKU Diag-Kit-3-Hexa Series · Examination Kit; Mirror, Cotton plier, Explorer, 3/Pk. SKU Diag-Kit-3-Slim Series | — | — |
| Viarden Lab LLC | United States | Maker | MINUTE FLUOR GEL, FLUOR FOAM, VIAR VEENER, AQUA FLUOR | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | varnish | — | — |
| Soher Med Limited | Hong Kong SAR China | Foreign exporter | varnish | — | — |
| Shenzhen Upcera Digital Dental Technology Co., Ltd | China | Foreign exporter | Ceramic Etchant (HF-5 and HF-9) | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 8 Oct 2019 | K191133 | KATANA Cleaner, KATANA Cleaner (Trial) | Kuraray Noritake Dental, Inc. |
| 14 Apr 2017 | K163171 | CeraClean | Bisco, Inc. |
| 16 Dec 2015 | K152322 | Resolve 2.0 | Denali Corporation |
Official records: FDA product classification for PME · 21 CFR 872.3260.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026