Identity
- Trade Name
- Nanoceram-Bright 0.25g x 20 C4 EUDAMEDNANOCERAM-BRIGHT FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Light Curing Nanohybrid Composite EUDAMEDLight curing, nanohybrid universal composite. Radiopaque resin-based dental restorative material for anterior and posterior restorations. FDA UDI
- Model / Reference
- 160122514 EUDAMEDC4, 0.25g x 20 FDA UDI
- Description
- Light curing, nanohybrid universal composite. Radiopaque resin-based dental restorative material for anterior and posterior restorations. FDA UDI
Identifiers
- Catalog Number
- 160122514 FDA UDI
- Primary DI / UDI-DI
- 05206569885149 EUDAMEDFDA UDI
- Basic UDI-DI
- 5206569COMP43SC 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
- Greece EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
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
Nanoceram-Bright by Dmp Dental Industry S.a. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental composite resin.
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- SimpliShade — KERR CORPORATION · Class II
- Bright Flow Core DC 5ml Dentine — DMP Dental Industry S.A. · Class IIa
- 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 Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Dmp Dental Industry S.a.
Sources (2)
- FDA UDI 7260e673-8938-4d8f-9801-ddaaa555358f 36 fields · synced Jul 24, 2026
- EUDAMED 67530f37-c8e8-4057-997c-21135d13480f 61 fields · synced Jul 24, 2026