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Sign in to claim this brandPARKELL, INC.
United States·US-MF-000003761
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 300, Executive Drive, Edgewood, United States
- Website
- www.parkell.com
- —
- —
- [email protected]
- Phone
- 6312491134
- PRRC Contact
- Yasily Ogando
- EUDAMED SRN
- US-MF-000003761
- FDA FEI Number
- 2411797
- DUNS Number
- 009900424
Catalogue (798)
Page 14 of 16| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Retract Gingival Retraction/Hemostatic Paste | K113839 | FDA 510(k) | U | Active |
| Parkell Resin Glaze | K040599 | FDA 510(k) | Class II | Active |
| Durafinish All-Cure, Model S296 | K080549 | FDA 510(k) | Class II | Active |
| Absolute Dentin 2 | K132115 | FDA 510(k) | Class II | Active |
| Lc Temporary Filling | K012360 | FDA 510(k) | Class II | Active |
| Amalgamibond Plus | K960879 | FDA 510(k) | Class II | Active |
| Porcelain Etching Gel And Etching Gel Barrier | K884918 | FDA 510(k) | Class II | Active |
| Tri-Phasix Chromatic Alginate | K962741 | FDA 510(k) | Class II | Active |
| C&B-Metabond Radiopaque Powder | K950905 | FDA 510(k) | Class II | Active |
| Hema-Primer | K895750 | FDA 510(k) | Class II | Active |
| Digitest | K950237 | FDA 510(k) | Class II | Active |
| Metafil | K923867 | FDA 510(k) | Class II | Active |
| Model Ms-1 Handpiece | K983413 | FDA 510(k) | Class I | Active |
| Parkell Desensitizer Gel | K191103 | FDA 510(k) | Class II | Active |
| Parkell Pit and Fissure Sealant | K243254 | FDA 510(k) | Class II | Active |
| Connect | K900303 | FDA 510(k) | Class II | Active |
| Intra-Oral Irrigator | K933547 | FDA 510(k) | Class II | Active |
| Mousse, Polyvinyl Siloxane Impression Material | K905032 | FDA 510(k) | Class II | Active |
| Thermique | K022097 | FDA 510(k) | Class II | Active |
| Model Ms-2 Handpiece | K982050 | FDA 510(k) | Class I | Active |
| Ultrasonic Tooth Scaler Model Dsciop | K852540 | FDA 510(k) | Class II | Active |
| Foramatron V, Model D680 | K002195 | FDA 510(k) | U | Active |
| Comp. E | K032179 | FDA 510(k) | Class II | Active |
| Secure | K073698 | FDA 510(k) | Class II | Active |
| HyperFil-LV | K182296 | FDA 510(k) | Class II | Active |
| Safe-T-Pins Retentive Pin System | K760723 | FDA 510(k) | Class I | Active |
| Temporary Resin Cement | K031212 | FDA 510(k) | Class II | Active |
| Mucohard | K053516 | FDA 510(k) | Class II | Active |
| Csr | K974865 | FDA 510(k) | Class II | Active |
| Primer-P Adhesive Agent | K896719 | FDA 510(k) | Class II | Active |
| SmarTemp X1 | K190930 | FDA 510(k) | Class II | Active |
| Parkell® | S308 | EUDAMEDFDA UDI | Class I | Active |
| Cinch® | S435 | EUDAMEDFDA UDI | Class I | Active |
| Hyperfil® | S326 | EUDAMEDFDA UDI | Class IIa | Active |
| AccuFilm II | S021 | EUDAMEDFDA UDI | Class I | Active |
| Absolute Dentin® | S307 | EUDAMEDFDA UDI | Class IIa | Active |
| Parkell® | D419 | EUDAMEDFDA UDI | Class I | Active |
| DryZ® | S182 | EUDAMEDFDA UDI | Class I | Active |
| Hedgehog™ | S498 | EUDAMEDFDA UDI | Class I | Active |
| AccuFilm | S020 | EUDAMEDFDA UDI | Class I | Active |
| Absolute Dentin® | S300 | EUDAMEDFDA UDI | Class IIa | Active |
| Parkell® | S620 | EUDAMEDFDA UDI | Class I | Active |
| Predicta™ | S610 | EUDAMEDFDA UDI | Class IIa | Active |
| Parkell® | DBI30 | EUDAMEDFDA UDI | Class IIa | Active |
| Parkell® | S344 | EUDAMEDFDA UDI | Class I | Active |
| Hyperfil® | S235 | EUDAMEDFDA UDI | Class IIa | Active |
| Hedgehog™ | S503 | EUDAMEDFDA UDI | Class I | Active |
| Parkell® | S349 | EUDAMEDFDA UDI | Class I | Active |
| Parkell® | D323 | EUDAMEDFDA UDI | Class I | Active |
| Predicta™ | S625 | EUDAMEDFDA UDI | Class IIa | Active |
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