Identity
- Trade Name
- Nanoceram-Bright 4g Bleach Extra 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
- 160111424 EUDAMEDBleach Extra, 4g FDA UDI
- Description
- Light curing, nanohybrid universal composite. Radiopaque resin-based dental restorative material for anterior and posterior restorations. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05206569884241 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
No
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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- NovaPro Fill — NANOVA BIOMATERIALS INC · Class II
- 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 cfa44a14-e43e-4df0-8fd6-bb132700ccc0 35 fields · synced Jul 11, 2026
- EUDAMED 3e04cfec-0482-4f99-ab50-dc7c7c27699e 61 fields · synced Jul 11, 2026