Duns Number:063005260
Device Description: Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, ni Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and repositioners. 3D scanned image of a patient's teeh
Catalog Number
SRI-0202015
Brand Name
NightGuard Flex
Version/Model Number
SRI-0202015
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K212448,K212448
Product Code
KMY
Product Code Name
Positioner, Tooth, Preformed
Public Device Record Key
687dbe7a-e4fb-4e63-93ad-c33349b0dd2a
Public Version Date
March 08, 2022
Public Version Number
1
DI Record Publish Date
February 28, 2022
Package DI Number
10850039704069
Quantity per Package
1
Contains DI Package
00850039704062
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 14 |