Duns Number:332025159
Device Description: SmileGuard is a light-curing material for the additive manufacuring of flexible, individua SmileGuard is a light-curing material for the additive manufacuring of flexible, individual dental bite splints.
Catalog Number
RES-01-3194
Brand Name
SmileGuard
Version/Model Number
RES-01-3194
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
-
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
K220894
Product Code
KMY
Product Code Name
Positioner, Tooth, Preformed
Public Device Record Key
e7ebdb59-dbb3-4ec1-b87a-838717d94839
Public Version Date
August 29, 2022
Public Version Number
1
DI Record Publish Date
August 19, 2022
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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |
| U | Unclassified | 2 |