Saturn M Rest Paste Additive (Two 5 g syringes) - Saturn M-Light, Self & Dual-Cure Core Build-Up - DENT ZAR, INC.

Duns Number:789664455

Device Description: Saturn M-Light, Self & Dual-Cure Core Build-Up Material (1:4 Formula)• in dual cure mode r 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.

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More Product Details

Catalog Number

0047

Brand Name

Saturn M Rest Paste Additive (Two 5 g syringes)

Version/Model Number

0047

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

EBF

Product Code Name

Material, Tooth Shade, Resin

Device Record Status

Public Device Record Key

b0e64bda-1b01-41b2-8d98-79bdfb83a6b1

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 03, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DENT ZAR, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 59