Is this your brand? Sign in to claim ownership.
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 3 of 16| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Snap™ | S481 | FDA UDI | Class II | Unknown |
| Snap™ | S449 | FDA UDI | Class II | Unknown |
| Turbo Piezo™ | D690110 | FDA UDI | Class II | Unknown |
| Parkell® | T-08 | FDA UDI | Class II | Active |
| Snap™ | S451 | FDA UDI | Class II | Unknown |
| Gentle Pulse™ | D636 | FDA UDI | Class II | Active |
| Aurora™ | D541 | FDA UDI | Class II | Active |
| Brush&Bond® | S242 | FDA UDI | Class II | Unknown |
| Parkell® | SD849-016 | FDA UDI | Class I | Unknown |
| Epic® | S358 | FDA UDI | Class II | Active |
| Parkell® | SDS-368-021C | FDA UDI | Class I | Active |
| Sharp™ | S514 | FDA UDI | Class II | Unknown |
| C.i.™ | S103 | FDA UDI | Class I | Active |
| Parkell® | SDS-862-014M | FDA UDI | Class I | Active |
| Dryz™ | S188UD | FDA UDI | U | Unknown |
| C&B Metabond® | S395 | FDA UDI | Class II | Active |
| Sensimatic™ | D703-K | FDA UDI | Class II | Unknown |
| Parkell® | SDS-856-018SC | FDA UDI | Class I | Active |
| Parkell® | SD120 | FDA UDI | Class I | Unknown |
| Parkell® | D554 | FDA UDI | Class II | Active |
| Absolute Dentin™ | S304 | FDA UDI | Class II | Unknown |
| Gripper™ Soft Copper Band | S702-09 | FDA UDI | Class I | Unknown |
| Brush&Bond® | S240 | FDA UDI | Class II | Unknown |
| HyperFIL™ | S321 | FDA UDI | Class II | Unknown |
| Parkell® | SDS-SE4F | FDA UDI | Class I | Unknown |
| Snap™ | S449 | FDA UDI | Class II | Active |
| Parkell® | SD368-016 | FDA UDI | Class I | Unknown |
| Snap™ | S468 | FDA UDI | Class II | Unknown |
| Foramatron® | D611 | FDA UDI | U | Active |
| GentleCLEAN™ | DSG30GCP | FDA UDI | Class II | Unknown |
| Parkell® | SDS-859-016M | FDA UDI | Class I | Active |
| Parkell® | SDS-837-014M | FDA UDI | Class I | Unknown |
| TurboVue™ | DLH30U | FDA UDI | Class II | Unknown |
| Parkell® | SDS-368-023M | FDA UDI | Class I | Active |
| Epic® | S358UD | FDA UDI | Class II | Unknown |
| AccuFilm® | S020-K | FDA UDI | Class I | Active |
| Parkell® | SD320-2 | FDA UDI | Class I | Unknown |
| AccuFilm® | Arch | FDA UDI | Class I | Unknown |
| 20/20™ | S475 | FDA UDI | Class I | Active |
| Gentle Pulse™ | D625-K | FDA UDI | Class II | Active |
| AccuFilm® | S021-K | FDA UDI | Class I | Active |
| Parkell® | SD520-4 | FDA UDI | Class I | Unknown |
| DuraFinish™ | S296 | FDA UDI | Class II | Active |
| Sensimatic™ | D633CK | FDA UDI | Class II | Unknown |
| Parkell® | S246 | FDA UDI | Class II | Unknown |
| Absolute Dentin™ | S304-K | FDA UDI | Class II | Unknown |
| MetaSeal® | S162 | FDA UDI | Class II | Active |
| Parkell® | SDS-805-014M | FDA UDI | Class I | Active |
| SEcure® | S273 | FDA UDI | Class II | Active |
| SmarTemp® | S337 | FDA UDI | Class II | Unknown |
Related Companies
Authorised Representatives
- Directa AB SE
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.