Identity
- Trade Name
- Atlas Dual Cure Cement, Single Carthridge FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Atlas is used for: final cementation of implant prosthesis, crowns, bridges, in-lays, on-lays, Maryland bridges, veneers, cementation of posts and pins, pit and fissure sealants, periodontal splinting, and cementation of orthodontic bands and appliances.. OUTSTANDING FEATURES OF THE MATERIAL •Excellent handling characteristics •Dual-Cured •Fluoride release •X-ray opacity •Low irritation potential •Negligible solubility •Low film thickness •Excellent resistance to oral environment and mechanical strength assure good long-term performance •Long shelf life FDA UDI
- Model / Reference
- 0007 FDA UDI
- Description
- Atlas is used for: final cementation of implant prosthesis, crowns, bridges, in-lays, on-lays, Maryland bridges, veneers, cementation of posts and pins, pit and fissure sealants, periodontal splinting, and cementation of orthodontic bands and appliances.. OUTSTANDING FEATURES OF THE MATERIAL •Excellent handling characteristics •Dual-Cured •Fluoride release •X-ray opacity •Low irritation potential •Negligible solubility •Low film thickness •Excellent resistance to oral environment and mechanical strength assure good long-term performance •Long shelf life FDA UDI
Identifiers
- Catalog Number
- 1007 FDA UDI
- Primary DI / UDI-DI
- D83610050 FDA UDI
- FDA Product Code
- DYH FDA UDI
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3750 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
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 composite resin
Atlas Dual Cure Cement, Single Carthridge by Dent Zar, 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
- Dent Zar, Inc.
Sources (1)
- FDA UDI 6739364e-7728-4ead-bb0c-b9a38ef02fb0 34 fields · synced May 30, 2026