Duns Number:080341158
Device Description: Good Fit Denture Teeth - Set (6 Teeth) - Lower Anterior - GL1 - A2
Catalog Number
-
Brand Name
Good Fit Denture Teeth
Version/Model Number
817610020232
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K931162
Product Code
ELM
Product Code Name
Denture, Plastic, Teeth
Public Device Record Key
dd8cf75f-db35-4fd1-801f-900488b7a962
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 09, 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 | 53 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 216 |