Identity
- Trade Name
- Saturn M Rest Paste Additive (Two 5 g syringes) FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Saturn M-Light, Self & Dual-Cure Core Build-Up Material (1:4 Formula) • in dual cure mode restorative pastes are mixed with accelerators, this permits complete set of the material irrespective of the thickness of the restoration, or the accessibility of light. • Virtually unlimited working time in light-cure mode; convenient working time in self-cure mode. • Well-balanced x-ray opacity permits easy distinguishing from tooth structure, pins and posts. • Moldable, non sticky consistency. • Allows one to control consistency, whenever desirable, by adding either liquid or paste-type catalyst for dual cure. • Contains moderately hard filler for easier carving and shaping. • Does not require refrigeration: long shelf life at ambient temperatures. • The Standard Saturn M kit contains two shades: contrasting for easy distinguishing from tooth structure; and the natural for use under semi-transparent ceramics. FDA UDI
- Model / Reference
- 0047 FDA UDI
- Description
- Saturn M-Light, Self & Dual-Cure Core Build-Up Material (1:4 Formula) • in dual cure mode restorative pastes are mixed with accelerators, this permits complete set of the material irrespective of the thickness of the restoration, or the accessibility of light. • Virtually unlimited working time in light-cure mode; convenient working time in self-cure mode. • Well-balanced x-ray opacity permits easy distinguishing from tooth structure, pins and posts. • Moldable, non sticky consistency. • Allows one to control consistency, whenever desirable, by adding either liquid or paste-type catalyst for dual cure. • Contains moderately hard filler for easier carving and shaping. • Does not require refrigeration: long shelf life at ambient temperatures. • The Standard Saturn M kit contains two shades: contrasting for easy distinguishing from tooth structure; and the natural for use under semi-transparent ceramics. FDA UDI
Identifiers
- Catalog Number
- 0047 FDA UDI
- Primary DI / UDI-DI
- D83600471 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
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
Saturn M Rest Paste Additive (Two 5 g syringes) 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 b0e64bda-1b01-41b2-8d98-79bdfb83a6b1 34 fields · synced May 30, 2026