Etchmaster - PrepMaster®- Mini disposable Cavity Preparation - GROMAN INC.

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.

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More Product Details

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

Product Characteristics

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 Details

Product Code

KOJ

Product Code Name

Airbrush

Device Record Status

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

Additional Identifiers

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