Identity
- Trade Name
- Seal·it With FineEtch EUDAMED
- Device Name
- Seal·it EUDAMED
- Model / Reference
- #8216P04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809262954432 EUDAMED
- Basic UDI-DI
- 880926295SI3A EUDAMEDB-08809262954432 EUDAMED
- Direct Marketing DI
- 08809262954432 EUDAMED
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Dental appliance fabrication material, ceramic
Seal·it With FineEtch by Spident — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental appliance fabrication material, ceramic.
- Razor / MegaPlus — U&C International Co., Ltd · Class II
- rainbow High shine — Genoss · Class II
- Bloomden — Bloomden Bioceramics (Hunan) Co., Ltd. · Class II
- Multi M Series — DMAX Co., Ltd. · Class II
- Multi M Series — DMAX Co., Ltd. · Class II
- BruxZir Shaded 16 PLUS — PRISMATIK DENTALCRAFT, INC. · Class II
- CGI — CERAGROUP INDUSTRIES · Class II
- ARENA Star — ARUM DENTISTRY Co., Ltd. · Class II
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 880926295SI3A | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 880926295SI3A | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Spident
- EUDAMED SRN
- KR-MF-000008691
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (2)
- EUDAMED 855d929c-a87f-4f4e-91a6-fee05c93891e 61 fields · synced Aug 2, 2026
- EUDAMED bf8efce7-ae82-49cb-a9a0-f9c5f4b23033 61 fields · synced Aug 2, 2026