Experience 11-2C04-SK02

GUDID D788112C04SK021

EXC MBT 022/U5-5 SK

Gc Orthodontics America Inc.

Orthodontic bracket, ceramic

• Primary Device ID: D788112C04SK021
• NIH Device Record Key: a42547b6-da87-4600-905b-61f70ddbb3b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Experience
• Version Model Number: 11-2C04-SK02
• Catalog Number: 11-2C04-SK02
• Company DUNS: 063167128
• Company Name: Gc Orthodontics America Inc.
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D788112C04SK020 [Unit of Use]
HIBCC	D788112C04SK021 [Primary]

FDA Product Code

• NJM: Bracket, ceramic, orthodontic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-08-15

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