Identity
- Trade Name
- Skyrock M P/L Core Build Up Material FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- • Skyrock M is a paste/liquid system. • Well-balanced x-ray opacity permits easy distinguishing from tooth structure, pins and posts. • It is moldable and non-sticky yet has an adhesive consistency. • Allows one to control consistency, wherever desirable, by adding more or less liquid. • Contains moderately hard filler for easier carving and shaping. • Does not require refrigeration: long shelf life at ambient temperatures. • Standard Skyrock M kit comes in two shades: one is contrasting, for easy distinguishing from tooth structure; the other is natural, for use under semi-transparent ceramics. FDA UDI
- Model / Reference
- 1015 FDA UDI
- Description
- • Skyrock M is a paste/liquid system. • Well-balanced x-ray opacity permits easy distinguishing from tooth structure, pins and posts. • It is moldable and non-sticky yet has an adhesive consistency. • Allows one to control consistency, wherever desirable, by adding more or less liquid. • Contains moderately hard filler for easier carving and shaping. • Does not require refrigeration: long shelf life at ambient temperatures. • Standard Skyrock M kit comes in two shades: one is contrasting, for easy distinguishing from tooth structure; the other is natural, for use under semi-transparent ceramics. FDA UDI
Identifiers
- Catalog Number
- 1015 FDA UDI
- Primary DI / UDI-DI
- D83610151 FDA UDI
- FDA Product Code
- EBF FDA UDI
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3690 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
Yes
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
Skyrock M P/L Core Build Up Material 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 61059881-e397-41f8-8ec4-c5aabcdef602 34 fields · synced Jun 8, 2026