Duns Number:315471722
Device Description: TPH Spectra ST LV Intro Kit is a visible light cured, radiopaque, composite restorative fo TPH Spectra ST LV Intro Kit is a visible light cured, radiopaque, composite restorative for anterior and posterior restorations and cosmetic and functional reshaping of primary and secondary teeth. The Compules Tips Gunr is used for the extrusion and direct application of the Compules Tips. With its supporting accessories (Compules Tips Gun, Shade Guide) it can be classified as a convenience kit.
Catalog Number
642000
Brand Name
TPH Spectra ST
Version/Model Number
642000
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"
-
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
d0ddd6f8-7efd-4f53-9cfd-ea4a0622ed72
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 14, 2017
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. | 36 |