Identity
- Trade Name
- ENFORCE FRC™ FDA UDI
- Generic Name
- Dental reinforcing fibre FDA UDI
- Device Name
- A revolutionary new concept in bonded lingual retention and periodontal splinting from G&H® Enforce frc™ incorporates thousands of glass fiber strands bundled together with a pre-impregnated light cure adhesive that allows adaptation directly in the patient's mouth. The intergrated fiber bundle is both malleable and tacky - perfect characteristics for close adaptation and positive retention prior to curing. .032" (.8mm) passive diameter - may be flattened significantly during adaption. The strength and durability of glass fibers combined with filled composite Easy-to-apply chairside method - no pre-adaptation Bonds chemically and mechanically Compatible with all bis-GMA cure composites Metal free & biocompatible Low profile and aesthetic Labial or lingual placement IDEAL FOR MANY APPLICATIONS: Lingual upper & lower retention Diastema retention Segmented treatment adjunct Trauma or periodontal splinting Extraction site maintenance Compliments TAD mechanics FDA UDI
- Model / Reference
- ENFORCEKT FDA UDI
- Description
- A revolutionary new concept in bonded lingual retention and periodontal splinting from G&H® Enforce frc™ incorporates thousands of glass fiber strands bundled together with a pre-impregnated light cure adhesive that allows adaptation directly in the patient's mouth. The intergrated fiber bundle is both malleable and tacky - perfect characteristics for close adaptation and positive retention prior to curing. .032" (.8mm) passive diameter - may be flattened significantly during adaption. The strength and durability of glass fibers combined with filled composite Easy-to-apply chairside method - no pre-adaptation Bonds chemically and mechanically Compatible with all bis-GMA cure composites Metal free & biocompatible Low profile and aesthetic Labial or lingual placement IDEAL FOR MANY APPLICATIONS: Lingual upper & lower retention Diastema retention Segmented treatment adjunct Trauma or periodontal splinting Extraction site maintenance Compliments TAD mechanics FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10190886000540 FDA UDI
- 510(k) Number
- K063170 FDA UDI
- FDA Product Code
- EBI FDA UDI
- GMDN Term
- Dental reinforcing fibre FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3760 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
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
Yes
FDA UDI
Category: Dental reinforcing fibre
Enforce Frc™ by G&H Wire Company, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- G&H Wire Company, Inc.
Sources (1)
- FDA UDI d9c9d6ac-95ef-4671-a808-d1649753997f 36 fields · synced Jun 8, 2026