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Pearl Composite Luting Cement Auto-Mix System, Single Carthridge
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Pearl Composite Luting Cement Auto-Mix System, Single Carthridge FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Pearl is a self-cured, filled permanent cement designed for cementing conventional cast restorations on most vital and non-vital teeth. It also cements bonded bridges of both cast and etched (Maryland) and perforated base (Rochette) types. It is also suitable for cementing prefabricated laminate veneers, ceramic crowns, inlays, onlays, pins, posts and periodontal splinting. • Auto-mix system. • Versatile. • Predictable, controllable and reproducible working time. • Excellent biological and chemical resistance to oral environment. • Excellent adhesion to both the tooth and metal surfaces. • High compressive and diametral tensile strength. • Simplicity in application. FDA UDI
- Model / Reference
- 0004 FDA UDI
- Description
- Pearl is a self-cured, filled permanent cement designed for cementing conventional cast restorations on most vital and non-vital teeth. It also cements bonded bridges of both cast and etched (Maryland) and perforated base (Rochette) types. It is also suitable for cementing prefabricated laminate veneers, ceramic crowns, inlays, onlays, pins, posts and periodontal splinting. • Auto-mix system. • Versatile. • Predictable, controllable and reproducible working time. • Excellent biological and chemical resistance to oral environment. • Excellent adhesion to both the tooth and metal surfaces. • High compressive and diametral tensile strength. • Simplicity in application. FDA UDI
Identifiers
- Catalog Number
- 0004 FDA UDI
- Primary DI / UDI-DI
- D83600040 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
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
Pearl Composite Luting Cement Auto-Mix System, 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 6d6aa5a4-26d3-46b2-8e8d-4c663b89984b 34 fields · synced May 30, 2026