Identity
- Trade Name
- GrandTEC FDA UDI
- Generic Name
- Temporary dental crown/bridge FDA UDI
- Device Name
- Resin-impregnated light-curing glass-fibre strands for dental adhesive technique. Test Kit FDA UDI
- Model / Reference
- 1169 FDA UDI
- Description
- Resin-impregnated light-curing glass-fibre strands for dental adhesive technique. Test Kit FDA UDI
Identifiers
- Catalog Number
- 1169 FDA UDI
- Primary DI / UDI-DI
- E22111691 FDA UDI
- FDA Product Code
- EBI FDA UDIEBF FDA UDI
- GMDN Term
- Temporary dental crown/bridge FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3760 FDA UDI872.3690 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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: Temporary dental crown/bridge
GrandTEC by VOCO GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K102354 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- VOCO GmbH
Sources (1)
- FDA UDI dafd99dc-7547-4557-91e3-06d8ea20ff22 37 fields · synced May 30, 2026