Etchmaster

GUDID D798EMHAPR0

The Etchmaster System is intended for use in microetching a surface prior to bonding with an orthodontic adhesive. Contents: • (1) Pressure Regulating 4 Hole Handpiece Attachment • (5) Regular and (5) Lingual Small BE/50 Hard Abrasive Tips

RELIANCE ORTHODONTIC PRODUCTS INC

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• Primary Device ID: D798EMHAPR0
• NIH Device Record Key: 08af15d6-04b6-4304-a925-811275adf4ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Etchmaster
• Version Model Number: EMHAPR
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D798EMHAPR0 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-21
• Device Publish Date: 2021-07-13

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