Duns Number:020124663
Device Description: EtchMaster® disposable Small microetching tip prefilled with 50% Alum Oxide and 50% Sodium EtchMaster® disposable Small microetching tip prefilled with 50% Alum Oxide and 50% Sodium Bi-Carbonate (Color code marking BLUE) with Regular bend nozzle.
Catalog Number
EM-S-B-RB
Brand Name
Etchmaster
Version/Model Number
EM-S-B-RB
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
August 29, 2026
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
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,K030292
Product Code
KOJ
Product Code Name
Airbrush
Public Device Record Key
3550f0ce-37fb-4d94-9a01-c9c41599203a
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 27, 2016
Package DI Number
40817494020074
Quantity per Package
100
Contains DI Package
00817494020076
Package Discontinue Date
August 29, 2026
Package Status
In Commercial Distribution
Package Type
Box