EXPERIENCE 19-2120-0007

GUDID D78819212000071

Exp CCO RH 022/UR2 10T 9A

Gc Orthodontics America Inc.

Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal

• Primary Device ID: D78819212000071
• NIH Device Record Key: a3a36c6f-015d-4753-8b7b-69946faa87b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXPERIENCE
• Version Model Number: 19-2120-0007
• Catalog Number: 19-2120-0007
• 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	D78819212000071 [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