Duns Number:789664455
Device Description: • Easy to apply; fast cure.• Outstanding depth of cure.• Reliable performance.• Good mecha • Easy to apply; fast cure.• Outstanding depth of cure.• Reliable performance.• Good mechanical strength and wear resistance allows for an extended service time of up to six months.• Good biocompatibility shares the same basic chemistry with light cured cavity liners.• Easy removal.• Compatible with all known permanent restoratives and cements.• Long shelf life with no need for refrigeration.• Versatility in use; also suitable for making temporary inlays and onlays, endodontic stopping and emergency temporization.
Catalog Number
0057
Brand Name
Accu Light Temporary Restorative, Single Syringe
Version/Model Number
0057
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
EBG
Product Code Name
Crown And Bridge, Temporary, Resin
Public Device Record Key
fec38d82-5a3b-4ea6-b60a-8c5dfa46ca88
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 |