Identity
- Trade Name
- FUSION-Zr - Veneer Cement FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- FUSION-Zr™ is a self-adhesive, light cure veneer cement and is indicated for the adhesive cementation of all-ceramic restorations, Feldspathic Porcelain, Lithium Disilicate and CAD/CAM type materials, where light curing is desired. FDA UDI
- Model / Reference
- New White - 0.6mL - Sample FDA UDI
- Description
- FUSION-Zr™ is a self-adhesive, light cure veneer cement and is indicated for the adhesive cementation of all-ceramic restorations, Feldspathic Porcelain, Lithium Disilicate and CAD/CAM type materials, where light curing is desired. FDA UDI
Identifiers
- Catalog Number
- 06-5520 FDA UDI
- Primary DI / UDI-DI
- D8370655200 FDA UDI
- 510(k) Number
- K073101 FDA UDI
- FDA Product Code
- EMA FDA UDI
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3275 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 0.6 Milliliter FDA UDI
Category: Dental composite resin
FUSION-Zr - Veneer Cement by Taub Products — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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 fbe385a0-cd83-4074-8cd9-621b1c11b7a3 38 fields · synced May 31, 2026