Duns Number:789664455
Device Description: • Skyrock M is a paste/liquid system.• Well-balanced x-ray opacity permits easy distinguis • 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.
Catalog Number
1015
Brand Name
Skyrock M P/L Core Build Up Material
Version/Model Number
1015
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
EBF
Product Code Name
Material, Tooth Shade, Resin
Public Device Record Key
61059881-e397-41f8-8ec4-c5aabcdef602
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 03, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |