AccessGUDID - DEVICE: Etchmaster (00817494020175)

GUDID

Device Identifier (DI) Information

Brand Name: Etchmaster
Version or Model: PM-X-L-RB
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PM-X-L-RB
Company Name: GROMAN INC.

Primary DI Number: 00817494020175
Issuing Agency: GS1
Commercial Distribution End Date: August 29, 2026
Device Count: 1
Labeler D-U-N-S® Number*: 020124663 *Terms of Use

Device Description: PrepMaster®- Mini disposable Cavity Preparation tip prefilled with 27 micron Aluminum Oxide (Color code marking BROWN) with Regular bend nozzle.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45403	Chairside dental abrasive air jet system	An assembly of devices that comprises a dental abrasive air jet system used to direct a concentrated jet of air combined with an abrasive powder, together with water for cooling, to the surface of the patient's tooth/teeth. It typically consists of a control unit, a dedicated intraoral handpiece and a foot switch that enables the dentist to control the abrasion process; some types are known as a sandblaster. It has a variety of applications such as, the removal of plaque and stains, cleaning fissures, the preparation of the tooth surface prior to bonding, the cleaning of orthodontic appliances (bands, brackets), the removal of adhesive residue and the cleaning of implants prior to loading.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KOJ	Airbrush

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K030292	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 617b114b-c1fc-4c9e-b28e-b6209b1e5c42
Public Version Date: July 03, 2026
Public Version Number: 4
DI Record Publish Date: September 27, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
50817494020170	25	30817494020176	2026-08-29	In Commercial Distribution	Box
30817494020176	25	00817494020175	2026-08-29	In Commercial Distribution	Box
40817494020173	16	30817494020176	2026-08-29	In Commercial Distribution	Box
20817494020179	5	00817494020175	2026-08-29	In Commercial Distribution	Bag
10817494020172	2	00817494020175	2026-08-29	In Commercial Distribution	Bag