Etchmaster EM-L-N-RB

GUDID 30817494020145

EtchMaster® disposable Large microetching tip prefilled with SYLC (Color code marking PINK) with Regular bend nozzle.

GROMAN INC.

Dental abrasive air jet system

• Primary Device ID: 30817494020145
• NIH Device Record Key: 11b76eed-2ff3-4e98-a121-555971051b30
• Commercial Distribution Discontinuation: 2026-08-29
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Etchmaster
• Version Model Number: EM-L-N-RB
• Catalog Number: EM-L-N-RB
• Company DUNS: 020124663
• Company Name: GROMAN 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-906-9298
• Email: Customerservice@Gromaninc.com
• Phone: 800-906-9298
• Email: Customerservice@Gromaninc.com
• Phone: 800-906-9298
• Email: Customerservice@Gromaninc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817494020144 [Primary]
GS1	10817494020141 [Package]; Contains: 00817494020144; Package: Bag [2 Units]; Discontinued: 2026-08-29; In Commercial Distribution
GS1	20817494020148 [Package]; Contains: 00817494020144; Package: Box [25 Units]; Discontinued: 2026-08-29; In Commercial Distribution
GS1	30817494020145 [Package]; Contains: 20817494020148; Package: Box [16 Units]; Discontinued: 2026-08-29; In Commercial Distribution

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: 2016-09-27

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• 00817494020021: EtchMaster® disposable Small microetching tip pre-filled with 50 micron Aluminum Oxide (Color c
• 40817494020012: EtchMaster® disposable Large microetching tip prefilled with 50 micron Aluminum Oxide (Color co
• 50817494020002: EtchMaster® disposable Large microetching tip prefilled with 50 micron Aluminum Oxide (Color co