Identity
- Trade Name
- Hyperfil® EUDAMEDHyperFIL™ FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- 10ml Universal Shade HyperFIL® - DC (Dual-Cure) EUDAMED10ml Universal Shade HyperFIL™ - DC (Dual-Cure) FDA UDI
- Model / Reference
- S326 EUDAMEDFDA UDI
- Description
- 10ml Universal Shade HyperFIL™ - DC (Dual-Cure) FDA UDI
Identifiers
- Catalog Number
- S326 FDA UDI
- Primary DI / UDI-DI
- 00810000525249 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00810000525249 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
- Not 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
Hyperfil® 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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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-00810000525249 | 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 (2)
- EUDAMED 8eb3b211-18a0-46b6-93bb-cdc54567e136 61 fields · synced Jul 18, 2026
- FDA UDI 7b1ccd83-d148-45a3-b88f-8e4e4e6f098d 37 fields · synced May 30, 2026