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Dia-Proseal
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 1003-201Model DIA-PROSEAL 16g
Identity
- Trade Name
- DIA-PROSEAL EUDAMEDFDA UDI
- Generic Name
- Endodontic filling/sealing material FDA UDI
- Device Name
- DIA-PROSEAL EUDAMEDDIA-PROSEAL Root Canal Sealer is two-component systems that react via an epoxide/amine chemical reaction to case setting. FDA UDI
- Model / Reference
- DIA-PROSEAL 16g EUDAMED1003-201 EUDAMED16g FDA UDI
- Description
- DIA-PROSEAL Root Canal Sealer is two-component systems that react via an epoxide/amine chemical reaction to case setting. FDA UDI
Identifiers
- Catalog Number
- 1003-201 FDA UDI
- Primary DI / UDI-DI
- 08806383551021 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08806383551021 EUDAMED
- FDA Product Code
- KIF FDA UDI
- EMDN Code
- Q01010201 ROOT CANAL FILLING DENTAL PASTES EUDAMED
- GMDN Term
- Endodontic filling/sealing material FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3820 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental coating, tooth-desensitizing
Dia-Proseal by Diadent Group International — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K182009 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08806383551021 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Diadent Group International
- EUDAMED SRN
- KR-MF-000023806
- Authorised Representative
- Diadent Europe B.V. NL-AR-000012597
Sources (3)
- EUDAMED bd36336f-5628-470e-884f-f28f1dd410bd 61 fields · synced Jun 18, 2026
- FDA UDI 3d309d94-28a2-431d-b7db-0d176f0cea31 35 fields · synced May 30, 2026
- FDA 510(k) K182009 1 fields · synced May 18, 2026