Grandtec
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
by VOCO GmbH
Identity
- Trade Name
- GrandTEC EUDAMEDFDA UDI
- Generic Name
- Temporary dental crown/bridge FDA UDI
- Device Name
- GrandTEC EUDAMEDResin-impregnated light-curing glass-fibre strands for dental adhesive technique. FDA UDI
- Model / Reference
- 1168 EUDAMEDFDA UDIglass fiber strand EUDAMED1170 EUDAMED
- Description
- Resin-impregnated light-curing glass-fibre strands for dental adhesive technique. FDA UDI
Identifiers
- Catalog Number
- 1168 FDA UDI
- Primary DI / UDI-DI
- E22111681 EUDAMEDFDA UDIE22111701 EUDAMED
- Basic UDI-DI
- B-E22111701 EUDAMEDB-E22111681 EUDAMED
- 510(k) Number
- FDA Product Code
- EBI FDA 510(k)FDA UDI
- EMDN Code
- Q01020605 TEMPORARY DENTAL PROSTHESES EUDAMED
- GMDN Term
- Temporary dental crown/bridge FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 872.3760 FDA 510(k)
- Regulation Number
- 872.3760 FDA 510(k)FDA UDI
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
GrandTEC Reinforcing Strands are resin-impregnated, light-curing glass-fibre strands designed for dental adhesive techniques. These strands provide mechanical reinforcement to composite or flow composite materials, enhancing structural integrity in restorative procedures.
Used in traumatology, periodontics, orthodontics, conservative dentistry, and prosthodontics, these strands are supplied as single-use materials. Authorised under FDA 510(k) and MDD, they are intended for reinforcing dental restorations without requiring metal frameworks. The product is classified under the EBI product code and adheres to dental adhesive application standards.
Frequently asked questions
What clinical specialties commonly use GrandTEC Reinforcing Strands in their procedures?
GrandTEC Reinforcing Strands are primarily used in traumatology, periodontics, orthodontics, conservative dentistry, and prosthodontics. These strands are designed to reinforce dental restorations with composite or flow composite materials, providing mechanical support without the need for metal frameworks.
Are GrandTEC Reinforcing Strands intended for single-use or can they be reused?
GrandTEC Reinforcing Strands are explicitly supplied as single-use materials. This ensures sterility and safety for each patient, preventing cross-contamination and maintaining the integrity of the product for dental adhesive techniques.
How are GrandTEC Reinforcing Strands authorized for use in the United States and Europe?
GrandTEC Reinforcing Strands are authorized under the FDA’s 510(k) clearance process, classified as substantially equivalent to a predicate device, and also comply with the Medical Devices Directive (MDD) in Europe. These authorizations confirm their compliance with regulatory standards for dental adhesive reinforcement.
What type of materials are GrandTEC Reinforcing Strands made from, and how do they function?
GrandTEC Reinforcing Strands consist of resin-impregnated, light-curing glass-fibre strands. These strands are integrated into composite or flow composite materials to enhance their structural integrity, providing mechanical reinforcement for dental restorations without relying on metal frameworks.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: GrandTEC - Composites | VOCO GmbH, GrandTEC - Nano-Hybrid Composite | VOCO GmbH, GrandTEC - Dental Tribune International, GrandTEC 1168 Reinforcing Strands - Henry Schein Dental
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K102347 | Class II | Active |
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Manufacturer
- Manufacturer
- VOCO GmbH
Sources (4)
- FDA 510(k) K102347 24 fields · synced Oct 6, 2026
- FDA UDI 5b4478f8-239d-4664-b511-9fcf4ecaf333 37 fields · synced May 30, 2026
- EUDAMED 3b851f20-ba69-4c30-b435-855678c963bd 61 fields · synced Jun 20, 2026
- EUDAMED f79eb103-57de-4d8f-a1b1-0b89c5494867 61 fields · synced Jul 28, 2026