Duns Number:002065670
Device Description: Tooth Protector, Gardent, Adult Size, Molded in USA, Santoprene, Bag of 50 Pieces Bulk Pac Tooth Protector, Gardent, Adult Size, Molded in USA, Santoprene, Bag of 50 Pieces Bulk Packaged
Catalog Number
E-126-050
Brand Name
AincA®
Version/Model Number
E-126-050
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Safe
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
BRW
Product Code Name
Protector, dental
Public Device Record Key
a50dcc3b-2874-48d6-872d-944c7fc7b9db
Public Version Date
April 08, 2021
Public Version Number
1
DI Record Publish Date
March 31, 2021
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 | 561 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 135 |