EXPERIENCE 19-243D-0007

GUDID D78819243D00071

Exp CCO RH 022/LR3 -8T 3A HK

Gc Orthodontics America Inc.

Orthodontic bracket, metal

• Primary Device ID: D78819243D00071
• NIH Device Record Key: 950c0a69-e79f-4b5c-b353-b6fe17c872e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXPERIENCE
• Version Model Number: 19-243D-0007
• Catalog Number: 19-243D-0007
• Company DUNS: 063167128
• Company Name: Gc Orthodontics America Inc.
• Device Count: 1
• 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: 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: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D78819243D00071 [Primary]

FDA Product Code

• EJF: BRACKET, METAL, ORTHODONTIC

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: 2023-03-22
• Device Publish Date: 2023-03-14

On-Brand Devices [EXPERIENCE]

• D788115CE300101: EXC TGO 020/U5-5/L3-3, 3HK
• D788115CC3SK031: EXC/M TGO/ROTH 022/U5-5/L5-5 SK
• D788115CC3SK021: EXC/M TGO/ROTH 022/U5-5/L5-5 SK
• D788115CC3SK011: EXC TGO/ROTH 022/U5-5/L3-3 SK
• D788115C0300101: EXC TGO 020/U5-5, 3HK
• D788115BA5SK011: EXC/M TGO/ROTH 022/U6-6/L7-7 SK
• D788115BA4SK011: EXC/MM TGO/ROTH 022/U6-6/L7-7 SK
• D78811541000101: EXC TGO 020X028/LR1&2 -1T 2A 0OF
• D78811531000101: EXC TGO 020X028/LL1&2 -1T 2A 0OF
• D78811522000101: EXC TGO 020X028/UL2 8T 9A
• D78811521000101: EXC TGO 020X028/UL1 12T 5A
• D78811512000101: EXC TGO 020X028/UR2 8T 9A
• D78811511000101: EXC TGO 020X028/UR1 12T 5A
• D788112EE300301: EXC XT 022/U3-3/L3-3, 3HK
• D788112EE300201: EXC MBT 022/U3-3/L3-3, 3HK
• D788112EE300101: EXC ROTH 022/U3-3/L3-3, 3HK
• D788112EE000101: EXC ROTH 022/U3-3/L3-3
• D788112E03SK011: EXC MBT/XT 022/U3-3 SK
• D788112E0300301: EXC XT 022/U3-3, 3HK
• D788112E0300201: EXC MBT 022/U3-3, 3HK
• D788112E0300101: EXC ROTH 022/U3-3, 3HK
• D788112E0000101: EXC ROTH 022/U3-3
• D788112CE500301: EXC XT 022/U5-5/L3-3, 3,4,5HK
• D788112CE500201: EXC MBT 022/U5-5/L3-3, 3,4,5HK
• D788112CE500101: EXC ROTH 022/U5-5/L3-3, 3,4,5HK
• D788112CE3SK011: EXC ROTH/XT 022/U5-5/L3-3 SK
• D788112CE300301: EXC XT 022/U5-5/L3-3, 3HK
• D788112CE300201: EXC MBT 022/U5-5/L3-3, 3HK
• D788112CE300101: EXC ROTH 022/U5-5/L3-3, 3HK
• D788112CE000101: EXC ROTH 022/U5-5/L3-3
• D788112CC5SK011: EXC/M XT 022/U5-5/L5-5 SK
• D788112CC5M0101: EXC ROTH 022/U5-5/L5-5, 3,4,5HK
• D788112CC4SK021: EXC/M ROTH 022/U5-5/L5-5 SK
• D788112CC4SK011: EXC/M ROTH/XT 022/U5-5/L5-5 SK
• D788112CC3SK011: EXC/M ROTH 022/U5-5/L5-5 SK
• D788112CC3M0101: EXC ROTH 022/U5-5/L5-5, 3HK
• D788112C0500301: EXC XT 022/U5-5, 3,4,5HK
• D788112C0500201: EXC MBT 022/U5-5, 3,4,5HK
• D788112C0500101: EXC ROTH 022/U5-5, 3,4,5HK
• D788112C04SK031: EXC MBT 022/U5-5 SK
• D788112C04SK021: EXC MBT 022/U5-5 SK
• D788112C04SK011: EXC ROTH/XT 022/U5-5 SK
• D788112C0300301: EXC XT 022/U5-5, 3HK
• D788112C0300201: EXC MBT 022/U5-5, 3HK
• D788112C0300101: EXC ROTH 022/U5-5, 3HK
• D788112C0000101: EXC ROTH 022/U5-5
• D788112BB3SK011: EXC/M MBT/XT 022/U6-6/L6-6 SK
• D788112AA5SK011: EXC/M MBT 022/U7-7/L7-7 SK
• D78811261000301: EXC XT 022/L1&2 1T 0A
• D78811261000201: EXC MBT 022/L1&2 -6T 0A