Etchmaster

Basic Information

• Brand Name: Etchmaster
• Primary DI: 00817494020106
• Version / Model: EM-L-G-RB
• Catalog Number: EM-L-G-RB
• Company Name: GROMAN INC.
• Labeler DUNS: 020124663
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-27
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 1318cb89-76ec-443a-89e5-87a7cde191d5
• Distribution End Date: 2026-08-29

Device Description

EtchMaster® disposable Large microetching tip prefilled with Sodium Bi-Carbonate (Color code marking GREEN) with Regular bend nozzle.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KOJ	Airbrush	Dental	872.6080	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45403	Dental abrasive air jet system	An assembly of devices that together comprise 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 or teeth. It typically consists of a control unit, a dedicated handpiece and a foot switch that enables the dentist to control the abrasion process. It has a wide variety of applications such as, the removal of plaque and stains, cleaning fissures (above and below the gingival), the preparation of the tooth surface prior to bonding, the cleaning of orthodontic appliances (bands and brackets), the removal of adhesive residue and the cleaning of implants prior to loading.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20817494020100	GS1	Box	25	In Commercial Distribution	2026-08-29
Primary	00817494020106	GS1
Package	10817494020103	GS1	Bag	2	In Commercial Distribution	2026-08-29

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K030292	000