Duns Number:020124663
Device Description: PrepMaster®- Mini disposable Cavity Preparation tip prefilled with 27 micron Aluminum Oxid PrepMaster®- Mini disposable Cavity Preparation tip prefilled with 27 micron Aluminum Oxide (Color code marking BROWN) with Regular bend nozzle.
Catalog Number
PM-X-L-RB
Brand Name
Etchmaster
Version/Model Number
PM-X-L-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,K030292
Product Code
KOJ
Product Code Name
Airbrush
Public Device Record Key
617b114b-c1fc-4c9e-b28e-b6209b1e5c42
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 27, 2016
Package DI Number
50817494020170
Quantity per Package
25
Contains DI Package
30817494020176
Package Discontinue Date
August 29, 2026
Package Status
In Commercial Distribution
Package Type
Box