Etchmaster EMHA

GUDID D798EMHA0

The Etchmaster System is intended for use in microetching a surface prior to bonding with an orthodontic adhesive This kit contains an Etchmaster 4 hole handpiece adapter, 5 small lingual tips and 5 small regular tips. 50 micron aluminum oxide

RELIANCE ORTHODONTIC PRODUCTS INC

Dental abrasive air jet system

• Primary Device ID: D798EMHA0
• NIH Device Record Key: 9dafb67a-500b-48cc-b94b-f1bc64cdec3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Etchmaster
• Version Model Number: EMHA
• Catalog Number: EMHA
• Company DUNS: 113170088
• Company Name: RELIANCE ORTHODONTIC PRODUCTS INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D798EMHA0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030292

FDA Product Code

• KOJ: Airbrush

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-03

On-Brand Devices [Etchmaster]

• D798EMTRS1: The Etchmaster system is intended for use for polishing, roughening and/or etching of tooth surf
• D798EMTRL1: The Etchmaster system is intended for use is for polishing, roughening and/or etching of tooth s
• D798EMTLS1: The Etchmaster system is intended for use for polishing, roughening, and/or etching of tooth sur
• D798EMTLL1: The Etchmaster System is intended for polishing, roughening and/or etching of tooth surfaces, en
• D798EMHAR0: The Etchmaster system is intended for use as a microetcher of a surface prior to bonding with an
• D798EMHA0: The Etchmaster System is intended for use in microetching a surface prior to bonding with an ort
• D798EMGAS0: The Etchmaster Gasket is designed for use with the Etchmaster 4 hole handpiece adapter.
• D798EMCO20: The Etchmaster CO2 cartridges are intended to be used in conjunction with the Etchmaster Cordles
• D798EMHAPR0: The Etchmaster System is intended for use in microetching a surface prior to bonding with an ort