Duns Number:113170088
Device Description: GlassLok is intended for use as a dual cure glass ionomer band cement for use in an orthod GlassLok is intended for use as a dual cure glass ionomer band cement for use in an orthodontic or dental office.Kit contains: 100g GlassLok Powder, 75g GlassLok Liquid, Spatula, Mixing Pad and Measuring Scoop
Catalog Number
GLE
Brand Name
GlassLok
Version/Model Number
GLE
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K193388
Product Code
EMA
Product Code Name
Cement, Dental
Public Device Record Key
70b37bdc-cb04-4d34-9f22-cccae09e1831
Public Version Date
July 24, 2020
Public Version Number
2
DI Record Publish Date
May 15, 2020
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 | 73 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 279 |