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 4 of 16| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Snap™ | S427 | FDA UDI | Class II | Active |
| Epic® | S357UD | FDA UDI | Class II | Unknown |
| TurboVue™ | DLH30P | FDA UDI | Class II | Unknown |
| Sensimatic™ | D702 | FDA UDI | Class II | Active |
| PerioSonic® | D581 | FDA UDI | Class II | Unknown |
| Sensimatic™ | D703 | FDA UDI | Class II | Active |
| Epic® | S311 | FDA UDI | Class II | Unknown |
| Burnett Power-Tip™ | D695 | FDA UDI | Class II | Active |
| Brush&Bond® | S284 | FDA UDI | Class II | Unknown |
| Brush&Bond® | S220 | FDA UDI | Class II | Active |
| Sharp™ | S511 | FDA UDI | Class II | Unknown |
| Snap™ | S425 | FDA UDI | Class II | Unknown |
| Aurora™ | D541 | FDA UDI | Class II | Unknown |
| C.i.™ | S112 | FDA UDI | Class I | Active |
| Gripper™ Soft Copper Band | S702-19 | FDA UDI | Class I | Unknown |
| Gentle Pulse™ | D624MSE-K | FDA UDI | Class II | Unknown |
| Snap™ | S451-K | FDA UDI | Class II | Active |
| Blu-Mousse® | S440S-K | FDA UDI | Class II | Active |
| Aurora™ | D543 | FDA UDI | Class II | Unknown |
| SmarTemp® | S346-BL | FDA UDI | Class II | Unknown |
| Snap™ | S429 | FDA UDI | Class II | Unknown |
| Gripper™ Soft Copper Band | S702-15 | FDA UDI | Class I | Unknown |
| Snap™ | S479 | FDA UDI | Class II | Unknown |
| C.i.™ | S090 | FDA UDI | Class I | Active |
| Absolute Polishers™ | S086 | FDA UDI | Class I | Unknown |
| Comfort Grip™ | DCG30UNI-PF | FDA UDI | Class II | Unknown |
| Gentle Pulse™ | D636-K | FDA UDI | Class II | Active |
| Digitest™ | D640E | FDA UDI | Class II | Unknown |
| Absolute Dentin™ | S307 | FDA UDI | Class II | Unknown |
| Cinch™ | S463S | FDA UDI | Class II | Unknown |
| Aurora™ | D544 | FDA UDI | Class II | Unknown |
| Gentle Pulse™ | D631ADAPT | FDA UDI | Class II | Active |
| Cinch™ | S464S | FDA UDI | Class II | Unknown |
| Sensimatic™ | D634 | FDA UDI | Class II | Unknown |
| Epic® | S316 | FDA UDI | Class II | Unknown |
| Absolute Dentin™ | S306 | FDA UDI | Class II | Unknown |
| Parkell® | D576BL | FDA UDI | Class II | Unknown |
| Parkell® | SDS-909-035C | FDA UDI | Class I | Unknown |
| MucoHard™ | S487 | FDA UDI | Class II | Unknown |
| SEcure® | S271 | FDA UDI | Class II | Active |
| GentleCLEAN™ | DSG30GCT | FDA UDI | Class II | Unknown |
| MetaSEAL™ | S161 | FDA UDI | Class II | Unknown |
| TurboSENSOR +™ | D660-LOANER | FDA UDI | Class II | Active |
| Parkell® | D556 | FDA UDI | Class II | Active |
| Aurora™ | D549 | FDA UDI | Class II | Unknown |
| Parkell® | SDS-862-012M | FDA UDI | Class I | Active |
| Absolute Dentin™ | S301-K | FDA UDI | Class II | Active |
| C.i.™ | S110 | FDA UDI | Class I | Active |
| Sensimatic™ | D700SE230 | FDA UDI | Class II | Active |
| Epic® | S360 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
- Directa AB SE
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.