Duns Number:001496777
Device Description: Repair-It Advanced Denture Repair Kit repairs broken dentures and denture teeth in minutes Repair-It Advanced Denture Repair Kit repairs broken dentures and denture teeth in minutes: Fix breaks, replace loose teeth, and mend cracks.
Catalog Number
-
Brand Name
Repair-It
Version/Model Number
1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EBO
Product Code Name
Over The Counter Denture Repair Kit
Public Device Record Key
f16881eb-9b42-40d3-bfbc-298ca91a4738
Public Version Date
November 06, 2020
Public Version Number
3
DI Record Publish Date
July 27, 2016
Package DI Number
20010705400917
Quantity per Package
16
Contains DI Package
70010705400912
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |