Duns Number:113170088
Device Description: The Etchmaster System is intended for use in microetching a surface prior to bonding with The Etchmaster System is intended for use in microetching a surface prior to bonding with an orthodontic adhesive.Contents:• (1) Pressure Regulating 4 Hole Handpiece Attachment• (5) Regular and (5) Lingual Small BE/50 Hard Abrasive Tips
Catalog Number
-
Brand Name
Etchmaster
Version/Model Number
EMHAPR
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"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K030292
Product Code
KOJ
Product Code Name
Airbrush
Public Device Record Key
08af15d6-04b6-4304-a925-811275adf4ac
Public Version Date
July 21, 2021
Public Version Number
1
DI Record Publish Date
July 13, 2021
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 |