Optiglaze™ 001533

GUDID 04548161391934

Optiglaze™ Brush Round #1, 10 pieces per box

Gc America Inc.

Dental material application tool, single-use

• Primary Device ID: 04548161391934
• NIH Device Record Key: 32ae8b05-d520-4767-a573-9d578ff76c83
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Optiglaze™
• Version Model Number: 001533
• Catalog Number: 001533
• Company DUNS: 005473608
• Company Name: Gc America Inc.
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Expiration Date: true
• 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: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04548161391934 [Unit of Use]
GS1	14548161391931 [Primary]

FDA Product Code

• EBD: Coating, filling material, resin

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: 2022-08-15
• Device Publish Date: 2022-08-05

On-Brand Devices [Optiglaze™]

• 04548161391941: Optiglaze™ Brush Holder, 2 pieces per box
• 04548161391934: Optiglaze™ Brush Round #1, 10 pieces per box
• 04548161391927: Optiglaze™ Brush Flat #1, 10 pieces per box
• 14548161292122: OPTIGLAZE™ Color Clear HV (5 mL)
• 14548161292115: OPTIGLAZE™ Color Red (2.6 mL)
• 14548161292108: OPTIGLAZE™ Color Pink (2.6 mL)
• 14548161292092: OPTIGLAZE™ Color Lavender (2.6 mL)
• 14548161292085: OPTIGLAZE™ Color Olive (2.6 mL)
• 14548161292078: OPTIGLAZE™ Color Pink Orange (2.6 mL)
• 14548161292061: OPTIGLAZE™ Color Yellow (2.6 mL)
• 14548161292054: OPTIGLAZE™ Color White (2.6 mL)
• 14548161292047: OPTIGLAZE™Color C plus (2.6 mL)
• 14548161292030: OPTIGLAZE™ Color B plus (2.6 mL)
• 14548161283359: OPTIGLAZE™ Color Red Brown (2.6 mL)
• 14548161283342: OPTIGLAZE™ Color Orange (2.6 mL)
• 14548161283335: OPTIGLAZE™ Color Ivory White (2.6 mL)
• 14548161283328: OPTIGLAZE™ Color Grey (2.6 mL)
• 14548161283311: OPTIGLAZE™ Color Clear (5 mL)
• 14548161283304: OPTIGLAZE™ Color Blue (2.6 mL)
• 14548161283298: OPTIGLAZE™ Color A plus (2.6 mL)
• 14548161282765: OPTIGLAZE™Color Complete Set Contains: All color shades (2.6 mL each) and disposable palette
• 14548161282574: OPTIGLAZE™ OPTIGLAZE Contains: One (15 mL) bottle.