Identity
- Trade Name
- Rebilda DC EUDAMEDFDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Rebilda DC EUDAMEDDual-curing flowable core build-up and post luting system FDA UDI
- Model / Reference
- 1397 EUDAMEDFDA UDI
- Description
- Dual-curing flowable core build-up and post luting system FDA UDI
Identifiers
- Catalog Number
- 1397 FDA UDI
- Primary DI / UDI-DI
- E22113971 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E2210374000000000FV EUDAMED
- 510(k) Number
- K060893 FDA UDI
- FDA Product Code
- EBF FDA UDI
- EMDN Code
- Q0101010201 DENTAL BASE CEMENTS 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
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
Rebilda DC by VOCO GmbH — Class II — FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Cleared under the same submission
K060893 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- VOCO GmbH
Sources (2)
- FDA UDI fd17bb03-c0d2-4003-b782-15494e3c8c78 37 fields · synced Oct 8, 2026
- EUDAMED 37426867-b5fd-4e7f-990d-730e6098b887 61 fields · synced Jul 12, 2026