Is this your brand? Sign in to claim ownership.
Sign in to claim this brandInformation
- Country
- US
- Address
- —
- Website
- —
- —
- —
- [email protected]
- Phone
- 201-944-0511
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 689370711
Catalogue (111)
Page 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Temp It | K100413 | FDA 510(k) | Class II | Active |
| EsFlow PLUS | K250317 | FDA 510(k) | Class II | Active |
| Escom 100 | K110428 | FDA 510(k) | Class II | Active |
| Estemp Ne | K100290 | FDA 510(k) | Class II | Active |
| i-Sil | K161774 | FDA 510(k) | Class II | Active |
| Hexa-Temp | K214071 | FDA 510(k) | Class II | Active |
| Core*it Dual | K092572 | FDA 510(k) | Class II | Active |
| Estemp Implant, Estemp Clear | K134021 | FDA 510(k) | Class II | Active |
| K-Bond Universal | K241445 | FDA 510(k) | Class II | Active |
| VioSeal | K242702 | FDA 510(k) | Class II | Active |
| FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack) | K242675 | EUDAMEDFDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.