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 11 of 16| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Epic® | S357 | FDA UDI | Class II | Unknown |
| Gripper™ Soft Copper Band | S702-13 | FDA UDI | Class I | Unknown |
| MetaSeal® | S161 | FDA UDI | Class II | Active |
| Parkell® | SDS-856-018C | FDA UDI | Class I | Active |
| Brush&Bond® | S286 | FDA UDI | Class II | Unknown |
| C.i.™ | S105 | FDA UDI | Class I | Active |
| Parkell® | SDS-858-014C | FDA UDI | Class I | Unknown |
| Epic® | S355 | FDA UDI | Class II | Unknown |
| MucoSoft® | S492S | FDA UDI | Class II | Unknown |
| Parkell® | SDS-834-021M | FDA UDI | Class I | Unknown |
| Parkell® | S276 | FDA UDI | Class II | Unknown |
| Parkell® | SDS-811-033C | FDA UDI | Class I | Unknown |
| TriPhasix™ | S403 | FDA UDI | Class II | Active |
| Add&Bond™ | S260 | FDA UDI | Class II | Active |
| Turbo Piezo™ | D690-230 | FDA UDI | Class II | Unknown |
| Parkell® | S151 | FDA UDI | Class I | Unknown |
| Parkell® | SDS-868-021VF | FDA UDI | Class I | Active |
| Epic® | S360UD | FDA UDI | Class II | Active |
| Epic® | S359UD | FDA UDI | Class II | Unknown |
| Snap™ | S444 | FDA UDI | Class II | Unknown |
| Snap™ | S426-K | FDA UDI | Class II | Active |
| Retrieve™ | S250 | EUDAMEDFDA UDI | Class II | Active |
| Metabond® | S399 | FDA UDI | Class II | Unknown |
| Parkell® | DSG30PP | FDA UDI | Class II | Unknown |
| Parkell® | SD285-5 | FDA UDI | Class I | Unknown |
| MucoSoft® | S491S | FDA UDI | Class II | Active |
| SEcure® | S273 | FDA UDI | Class II | Unknown |
| C.i.™ | S108 | FDA UDI | Class I | Active |
| Aurora™ | D547 | FDA UDI | Class II | Unknown |
| Absolute Dentin™ | S303 | FDA UDI | Class II | Active |
| GentleCLEAN™ | DSG30GCW | FDA UDI | Class II | Active |
| Aurora™ | D544 | FDA UDI | Class II | Unknown |
| Digitest™ | D640E-JM | FDA UDI | Class II | Active |
| TurboVue™ | D570110 | FDA UDI | Class II | Unknown |
| TurboVue™ | DLH30TRI | FDA UDI | Class II | Active |
| Foramatron® | D619WAE | FDA UDI | U | Unknown |
| SEcure® | S274 | FDA UDI | Class II | Unknown |
| Burnett Power-Tip™ | DSG30T | FDA UDI | Class II | Active |
| Parkell® | SD859-016 | FDA UDI | Class I | Unknown |
| SmarTemp® | S341 | FDA UDI | Class II | Unknown |
| Snap™ | S452 | FDA UDI | Class II | Unknown |
| Epic® | S317 | FDA UDI | Class II | Unknown |
| Amalgambond® | S376 | FDA UDI | Class II | Unknown |
| TurboSENSOR™ | D560-110DE | FDA UDI | Class II | Active |
| Epic® | S368 | FDA UDI | Class II | Unknown |
| Snap™ | S452 | FDA UDI | Class II | Unknown |
| Blu-Mousse® | S438 | FDA UDI | Class II | Unknown |
| Snap™ | S459-K | FDA UDI | Class II | Active |
| SmarTemp® | S346-B1 | FDA UDI | Class II | Unknown |
| Thermique™ | D531 | 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.