Etchmaster EMCO2

GUDID D798EMCO20

The Etchmaster CO2 cartridges are intended to be used in conjunction with the Etchmaster Cordless Handpiece as the air source.

RELIANCE ORTHODONTIC PRODUCTS INC

Dental abrasive air jet system Dental abrasive air jet system

• Primary Device ID: D798EMCO20
• NIH Device Record Key: a11ade8b-81b4-474f-8660-99546712a070
• Commercial Distribution Discontinuation: 2018-08-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Etchmaster
• Version Model Number: EMCO2
• Catalog Number: EMCO2
• Company DUNS: 113170088
• Company Name: RELIANCE ORTHODONTIC PRODUCTS INC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• 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	D798EMCO20 [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: 5
• Public Version Date: 2018-08-31
• Device Publish Date: 2016-09-09

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