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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 1 of 16| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Parkell® | SDS-838-010C | FDA UDI | Class I | Active |
| Absolute Dentin™ | S301 | FDA UDI | Class II | Unknown |
| SEcure® | S272 | FDA UDI | Class II | Active |
| Comfort Grip™ | DCG30SLIM-PF | FDA UDI | Class II | Unknown |
| Epic® | S367 | FDA UDI | Class II | Active |
| Cinch™ | S454S | FDA UDI | Class II | Unknown |
| Parkell® | D675 | FDA UDI | Class II | Unknown |
| E.t.c.™ | S255 | FDA UDI | Class II | Active |
| Parkell® | T-02 | FDA UDI | Class II | Active |
| Parkell® | SDS-837-012M | FDA UDI | Class I | Active |
| Turbo Piezo™ | D693 | FDA UDI | Class II | Active |
| Parkell® | SDS-835-014C | FDA UDI | Class I | Active |
| Sharp™ | S510 | FDA UDI | Class II | Unknown |
| Parkell® | SDS-909-042C | FDA UDI | Class I | Active |
| Parkell® | S195A | FDA UDI | Class I | Unknown |
| HyperFIL® | S236 | FDA UDI | Class II | Active |
| Parkell® | P-04 | FDA UDI | Class II | Active |
| Epic® | S365UD | FDA UDI | Class II | Unknown |
| Integra™ | D681 | FDA UDI | Class II | Active |
| Snap™ | S482 | FDA UDI | Class II | Unknown |
| Parkell® | SDS-847-016C | FDA UDI | Class I | Active |
| Aurora™ | D546230 | FDA UDI | Class II | Unknown |
| Parkell® | S446 | FDA UDI | Class I | Unknown |
| C&B MetaBond® | S385 | FDA UDI | Class II | Active |
| Digitest™ | D640 | FDA UDI | Class II | Unknown |
| Blu-Mousse® | S457S-K | FDA UDI | Class II | Active |
| C&B Metabond® | S393 | FDA UDI | Class II | Active |
| Epic® | S362 | FDA UDI | Class II | Active |
| Clean Machine™ | D60030KCR | FDA UDI | Class II | Unknown |
| Epic® | S363 | FDA UDI | Class II | Active |
| MetaSeal® | S163 | FDA UDI | Class II | Unknown |
| TurboVue™ & Burnett Power-Tip™ | DLH30T | FDA UDI | Class II | Unknown |
| Snap™ | S434 | FDA UDI | Class II | Unknown |
| Gentle Pulse™ | D624MSE | FDA UDI | Class II | Unknown |
| Sharp™ | S512 | FDA UDI | Class II | Unknown |
| Gripper™ Soft Copper Band | S702-01 | FDA UDI | Class I | Unknown |
| Parkell® | S521 | FDA UDI | Class II | Unknown |
| SmarTemp® | S340 | FDA UDI | Class II | Active |
| Comfort Grip™ | DCG30TRI-PF | FDA UDI | Class II | Unknown |
| Cinch™ | S454S | FDA UDI | Class II | Unknown |
| Cinch™ | S453S | FDA UDI | Class II | Unknown |
| Cinch™ | S460S | FDA UDI | Class II | Unknown |
| Parkell® | S421 | FDA UDI | Class II | Active |
| Parkell® | SD110-013 | FDA UDI | Class I | Unknown |
| Epic® | S367UD | FDA UDI | Class II | Unknown |
| MucoHard™ | S642 | FDA UDI | Class II | Active |
| Brush&Bond® | S285 | FDA UDI | Class II | Active |
| Gripper™ Soft Copper Band | S702-05 | FDA UDI | Class I | Unknown |
| Parkell | AP-1 1/2 | FDA UDI | Class II | Active |
| Parkell® | SD198-017 | FDA UDI | Class I | Unknown |
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