Duns Number:113170088
Device Description: The Etchmaster system is intended for use for polishing, roughening and/or etching of toot The Etchmaster system is intended for use for polishing, roughening and/or etching of tooth surfaces, enamel, dentin, and dental restorations for adhesive restorative procedures.This is the Etchmaster Regular Small Tips
Catalog Number
EMTRS
Brand Name
Etchmaster
Version/Model Number
EMTRS
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
K030292,K030292,K030292,K030292
Product Code
KOJ
Product Code Name
Airbrush
Public Device Record Key
f41ecca8-1f20-4075-82d0-cea22f2f98f8
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 04, 2016
Package DI Number
D798EMTRS2
Quantity per Package
50
Contains DI Package
D798EMTRS1
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Bag
| 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 |