Prime-Crown
by Prime Dental Manufacturing 11 variants
Ref 100-103A2Model TF13
Prime-Crown (100-103A2) is a medical device (EU MDD Class IIa; EMDN category temporary teeth resins) made by Prime Dental Manufacturing, registered in EUDAMED on 6 Jan 2026 (Basic UDI-DI 081744102TF135C), active as of 25 Oct 2026.
Active
CE MDR CE MDD
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | Number081744102TF135C 00817441022276 | Date6 Jan 2026 | StatusActive |
| European Union | CE/MDR | Number081744102TF135C 00817441022276 | Date6 Jan 2026 | StatusActive |
Official records
- EUDAMED public site 081744102TF135C
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD, CE/MDR Active
Specification
- Device name
- Dental Temporary Crown and Bridge Materials
- Model / reference
- TF13, 100-103A2
- Primary DI / UDI-DI
- 00817441022276
- Basic UDI-DI
- 081744102TF135C, B-00817441022276
- EMDN code
- Q0102050101 Temporary teeth resins
- Device class
- Class IIa
- EU registration type
- Standard deviceLegacy device (under a directive)
- EU market of registration
- ItalyGermany
Manufacturer details
- EUDAMED SRN
- US-MF-000008807
- Authorised representative
- MedEnvoy Global BV NL-AR-000024028
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