Etchmaster EM-S-O-RB

GUDID 50817494020163

EtchMaster® disposable Small microetching tip prefilled with 30 micron Glycine (Color code marking ORANGE) with Regular bend nozzle.

GROMAN INC.

Dental abrasive air jet system

• Primary Device ID: 50817494020163
• NIH Device Record Key: 7c13fb0a-f5e1-4f11-aa89-eb9bf3090f15
• Commercial Distribution Discontinuation: 2026-08-29
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Etchmaster
• Version Model Number: EM-S-O-RB
• Catalog Number: EM-S-O-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	00817494020168 [Primary]
GS1	10817494020165 [Package]; Contains: 00817494020168; Package: Bag [2 Units]; Discontinued: 2026-08-29; In Commercial Distribution
GS1	20817494020162 [Package]; Contains: 00817494020168; Package: Box [25 Units]; Discontinued: 2026-08-29; In Commercial Distribution
GS1	30817494020169 [Package]; Contains: 00817494020168; Package: Box [50 Units]; Discontinued: 2026-08-29; In Commercial Distribution
GS1	40817494020166 [Package]; Contains: 00817494020168; Package: Box [100 Units]; Discontinued: 2026-08-29; In Commercial Distribution
GS1	50817494020163 [Package]; Contains: 20817494020162; Package: Box [32 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

On-Brand Devices [Etchmaster]

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• 50817494020163: EtchMaster® disposable Small microetching tip prefilled with 30 micron Glycine (Color code mark
• 30817494020152: EtchMaster® disposable Large microetching tip prefilled with 90 micron Aluminum Oxide (Color co
• 30817494020145: EtchMaster® disposable Large microetching tip prefilled with SYLC (Color code marking PINK) wit
• 50817494020132: EtchMaster® disposable Small microetching tip prefilled with 3M Co-Jet (Color code marking BROW
• 30817494020121: EtchMaster® disposable Large microetching tip prefilled with Sodium Bi-Carbonate (Color code ma
• 40817494020111: EtchMaster® disposable Small microetching tip prefilled with Calcium Carbonate (Color code mark
• 20817494020100: EtchMaster® disposable Large microetching tip prefilled with Sodium Bi-Carbonate (Color code ma
• 40817494020098: EtchMaster® disposable Small microetching tip prefilled with Sodium Bi-Carbonate (Color code ma
• 20817494020087: EtchMaster® disposable Large microetching tip prefilled with 50% Alum Oxide and 50% Sodium Bi-C
• 40817494020074: EtchMaster® disposable Small microetching tip prefilled with 50% Alum Oxide and 50% Sodium Bi-C
• 40817494020067: EtchMaster® disposable Small microetching tip prefilled with 50 micron Glass Beads (Color code
• 10817494020059: EtchMaster® disposable Small microetching tip prefilled with 27 micron Aluminum Oxide (Color co
• 40817494020043: EtchMaster® disposable Large microetching tip prefilled with 27 micron Aluminum Oxide (Color co
• 00817494020038: EtchMaster® disposable Small microetching tip prefilled with 50 micron Aluminum Oxide (Color co
• 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