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Absolute Dentin®
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref S304Ref S305
by Parkell Inc.
Identity
- Trade Name
- Absolute Dentin® EUDAMEDAbsolute Dentin™ FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Absolute Dentin® EUDAMED10ml. Artic White Absolute Dentin™ (2 Cartridges; 20ml. Total) FDA UDI10ml. Tooth Shade Absolute Dentin™ (2 Cartridges; 20ml. Total) FDA UDI
- Model / Reference
- S304 EUDAMEDFDA UDIS305 EUDAMEDFDA UDI
- Description
- 10ml. Artic White Absolute Dentin™ (2 Cartridges; 20ml. Total) FDA UDI10ml. Tooth Shade Absolute Dentin™ (2 Cartridges; 20ml. Total) FDA UDI
Identifiers
- Catalog Number
- S304 FDA UDIS305 FDA UDI
- Primary DI / UDI-DI
- 10810000525048 EUDAMEDFDA UDI10810000525055 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10810000525048 EUDAMEDB-10810000525055 EUDAMED
- FDA Product Code
- EBF FDA UDI
- EMDN Code
- Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3690 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
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 composite resin
Absolute Dentin® by Parkell, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental composite resin.
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- Llis — Dentscare Ltda · Class II
- Capo Universal, 6 g — Schütz Dental GmbH · Class II
- OMNICHROMA — TOKUYAMA DENTAL CORPORATION · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-10810000525048 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Parkell Inc.
- EUDAMED SRN
- US-MF-000003761
- Authorised Representative
- Directa AB SE-AR-000002492
Sources (4)
- EUDAMED 276c2a51-4c0f-4269-8c03-ce30f101762d 61 fields · synced Jul 13, 2026
- FDA UDI 772785cc-5342-4cf0-99a4-d95c618cef57 36 fields · synced May 30, 2026
- FDA UDI f3456653-5f1c-4f5b-9782-165e36b2e483 36 fields · synced May 30, 2026
- EUDAMED 8aebf91b-9fb2-4720-909c-bf85e80d09b6 61 fields · synced Jul 13, 2026