ENFORCE FRC™
- Primary DI
- 10190886000533
- Brand
- ENFORCE FRC™
- Company
- G & H Wire Company, Inc.
- Model
- ENFORCE5
- Device description
- "TRIAL 5CMA 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 compositeEasy-to-apply chairside method - no pre-adaptationBonds chemically and mechanicallyCompatible with all bis-GMA cure compositesMetal free & biocompatibleLow profile and aestheticLabial or lingual placementIDEAL FOR MANY APPLICATIONS:Lingual upper & lower retentionDiastema retentionSegmented treatment adjunctTrauma or periodontal splintingExtraction site maintenanceCompliments TAD mechanics"
- Published
- 2016-09-24
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
Contact Domains#
Product Codes#
| Code | Name |
|---|---|
| EBI | Resin, Denture, Relining, Repairing, Rebasing |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| EBI | Resin, Denture, Relining, Repairing, Rebasing | Dental | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K063170 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10190886000533 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 10190886000533 | 10190886000533 |
GMDN Terms#
| Term | Definition |
|---|---|
| Dental reinforcing fibre | A device used in general restorative dentistry and orthodontic treatment typically as reinforcement of dental polymer-based materials, used for the construction of dental prostheses, i.e., splints, posts, crowns, and bridges. This device is typically made of polyethylene (PE) fibres supplied in strands, braid, or ribbon in a variety of sizes. It may also be used for the stabilization of avulsed teeth maintaining diastema closures or split-tooth syndrome. The ultrahigh molecular weight PE fibres increase the strength of composite materials, and provide improved safety by assisting in the retention of pieces in the event that a dental prosthesis is broken. This is a single-use device. |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Storage Environment Temperature | 36 Degrees Fahrenheit | 46 Degrees Fahrenheit |
Contacts#
| Phone | |
|---|---|
| +1 317-346-6655 | orders@ghortho.com |
Regulatory Flags#
- DUNS number
- 831465641
- Device count
- 1
- Lot or batch
- true
- Manufacturing date on label
- true
- Expiration date on label
- true
Other Devices From This Company#
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|---|---|---|---|---|
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| 10190886271629 | G&H ORTHODONTICS ® | 131-L5-8LK-V | 2026-02-27 | |
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| 10190886271858 | G&H ORTHODONTICS ® | 131-L5-2LK-V | 2026-02-27 | |
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| 10190886271032 | G&H ORTHODONTICS ® | 130-U1-8L-V | 2026-02-27 | |
| 10190886271049 | G&H ORTHODONTICS ® | 130-U2-8R-V | 2026-02-27 | |
| 10190886271056 | G&H ORTHODONTICS ® | 130-U2-8L-V | 2026-02-27 | |
| 10190886271063 | G&H ORTHODONTICS ® | 130-U3-8RK-V | 2026-02-27 | |
| 10190886271070 | G&H ORTHODONTICS ® | 130-U3-8LK-V | 2026-02-27 | |
| 10190886271087 | G&H ORTHODONTICS ® | 130-U4-8RK-V | 2026-02-27 | |
| 10190886271094 | G&H ORTHODONTICS ® | 130-U4-8LK-V | 2026-02-27 | |
| 10190886271100 | G&H ORTHODONTICS ® | 130-U4-8U-V | 2026-02-27 | |
| 10190886271117 | G&H ORTHODONTICS ® | 130-L1-8U-V | 2026-02-27 | |
| 10190886271124 | G&H ORTHODONTICS ® | 130-L3-8RK-V | 2026-02-27 | |
| 10190886271131 | G&H ORTHODONTICS ® | 130-L3-8LK-V | 2026-02-27 | |
| 10190886271148 | G&H ORTHODONTICS ® | 130-L4-8U-V | 2026-02-27 | |
| 10190886271155 | G&H ORTHODONTICS ® | 130-L4-8RK-V | 2026-02-27 | |
| 10190886271162 | G&H ORTHODONTICS ® | 130-L4-8LK-V | 2026-02-27 | |
| 10190886271179 | G&H ORTHODONTICS ® | 130-L5-8U-V | 2026-02-27 |
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| D14307560147448280 | Smart Dent ® | MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA. | EBI | 2026-05-29 |
| D14307560147448350 | Smart Dent ® | MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA. | EBI | 2026-05-29 |
| D14307560147449650 | Smart Dent ® | MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA. | EBI | 2026-05-29 |
| D14307560147450090 | Smart Dent ® | MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA. | EBI | 2026-05-29 |
| D14307560147450160 | Smart Dent ® | MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA. | EBI | 2026-05-29 |
| D14307560147451840 | Smart Dent ® | MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA. | EBI | 2026-05-29 |
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