Duns Number:113170088
Device Description: The Etchmaster System is intended for polishing, roughening and/or etching of tooth surfac The Etchmaster System is intended for polishing, roughening and/or etching of tooth surfaces, enamel, dentin, and dental restorations for adhesive restorative procedures.This is the Etchmaster Large Lingual Tips.
Catalog Number
EMTLL
Brand Name
Etchmaster
Version/Model Number
EMTLL
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
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
KOJ
Product Code Name
Airbrush
Public Device Record Key
134b8b2a-b94d-4ed2-9b18-7b69e5cdde51
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 04, 2016
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 |