← Back to catalogue
Dental Pit/Fissure Sealant
EUDAMEDClass IIa (EU MDR)
Ref Dental Pit/Fissure Sealant
Identity
- Trade Name
- Dental Pit/Fissure Sealant EUDAMED
- Device Name
- Dental Pit/Fissure Sealant EUDAMED
- Model / Reference
- Dental Pit/Fissure Sealant EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06935546103035 EUDAMED
- Basic UDI-DI
- B-06935546103035 EUDAMED
- EMDN Code
- Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Dental Pit/Fissure Sealant by AT&M Biomaterials Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06935546103035 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- AT&M Biomaterials Co., Ltd.
- EUDAMED SRN
- CN-MF-000010556
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 943988f9-1efe-48cb-8b0b-c78418eaf620 61 fields · synced Jun 18, 2026