Identity
- Trade Name
- FUSION Silane FDA UDI
- Generic Name
- Dental repair kit, ceramic FDA UDI
- Device Name
- A two-part silane system creating a stronger chemical bond to feldspathic porcelain, all ceramic restorations, and recommended for best adhesion to veneers, crowns and other ceramic restorations. Also use it for easy chair-side repairs to: porcelain-gold restorations, porcelain jackets, porcelain denture teeth, popped-out porcelain veneers or facings. Eliminates costly laboratory remakes. This non-toxic, non-irritating formula can be used in or out of the mouth. FDA UDI
- Model / Reference
- A FDA UDI
- Description
- A two-part silane system creating a stronger chemical bond to feldspathic porcelain, all ceramic restorations, and recommended for best adhesion to veneers, crowns and other ceramic restorations. Also use it for easy chair-side repairs to: porcelain-gold restorations, porcelain jackets, porcelain denture teeth, popped-out porcelain veneers or facings. Eliminates costly laboratory remakes. This non-toxic, non-irritating formula can be used in or out of the mouth. FDA UDI
Identifiers
- Catalog Number
- 06-2000 FDA UDI
- Primary DI / UDI-DI
- D8370620000 FDA UDI
- FDA Product Code
- EBO FDA UDI
- GMDN Term
- Dental repair kit, ceramic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 6 Milliliter FDA UDI
Category: Dental repair kit, ceramic
FUSION Silane by Taub Products — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental repair kit, ceramic.
- Interface A Bottle — Vista Dental · Class II
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- GC CERAMIC PRIMER II — Gc America Inc. · Class II
- ReVeneer Composite Filli — Schütz Dental GmbH · Class II
- EtchArrest — ULTRADENT PRODUCTS, INC. · Class II
- Etching Gel Kit — Cosmedent, Inc.
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
- Taub Products
Sources (1)
- FDA UDI 1bfb8bc7-093e-40ac-a4e3-b575d5e84155 37 fields · synced May 30, 2026