EXPERIENCE® 19-1BB5-8997

GUDID D788191BB589971

EXMRC Roth/MBT 018 U/L 6-6 HK345

Gc Orthodontics America Inc.

Orthodontic bracket, metal

• Primary Device ID: D788191BB589971
• NIH Device Record Key: 7ea4c940-ab76-4535-ad0f-04c78b37974a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXPERIENCE®
• Version Model Number: 19-1BB5-8997
• Catalog Number: 19-1BB5-8997
• 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: 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)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	D788191BB589971 [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: 2020-09-16
• Device Publish Date: 2020-09-08

On-Brand Devices [EXPERIENCE®]

• D788242CC500101: EXP METAL MINI RC ROTH 022/U5-5/L5-5HK
• D788242CC300201: EXP METAL MINI RC MBT 022/U5-5/L5
• D788242CC300101: EXP ME MINI RC ROTH022/U5-5/L5-5 3HK
• D78824261000201: EXRC MBT 022/L1&2 -6T 0A
• D78824245D00201: EXRC MBT 022/LR5 -17T 2A HK
• D78824245000201: EXRC MBT 022/LR5 -17T 2A
• D78824244D00201: EXRC MBT 022/LR4 -12T 2A HK
• D78824244000201: EXRC MBT 022/LR4 -12T 2A
• D78824243D00201: EXM MBT 022/LR3 -6T 3A HK
• D78824235D00201: EXRC MBT 022/LL5-17T 2A HK
• D78824235000201: EXRC MBT 022/LL5 -17T 2A
• D78824234D00201: EXRC MBT 022/LL4 -12T 2A HK
• D78824234000201: EXRC MBT 022/LL4 -12T 2A
• D78824233D00201: EXM MBT 022/LL3 -6T 3A HK
• D78824224D00201: EXRC MBT 022/UL4&5 -7T 0A HK
• D78824223D00201: EXRC MBT 022/UL3 -7T 8A HK
• D78824222000201: EXRC MBT 022/UL2 10T 8A
• D78824221000201: EXRC MBT 022/UL1 17T 4A
• D78824214D00201: EXRC MBT 022/UR4&5 -7T 0A HK
• D78824213D00201: EXRC MBT 022/UR3 -7T 8A HK
• D78824212000201: EXRC MBT 022/UR2 10T 8A
• D78824211000201: EXRC MBT 022/UR1 17T 4A
• D78824161000201: EXRC MBT 018/L1&2 -6T 0A
• D78824145D00201: EXRC MBT 018/LR5 -17T 2A HK
• D78824144D00201: EXRC MBT 018/LR4 -12T 2A HK
• D78824143D00201: EXRC MBT 018/LR3 -6T 3A HK
• D78824135D00201: EXRC MBT 018/LL5-17T 2A HK
• D78824134D00201: EXRC MBT 018/LL4 -12T 2A HK
• D78824133D00201: EXRC MBT 018/LL3 -6T 3A HK
• D78824124D00201: EXRC MBT 018/UL4&5 -7T 0A HK
• D78824123D00201: EXRC MBT 018/UL3 -7T 8A HK
• D78824122000201: EXRC MBT 018/UL2 10T 8A
• D78824121000201: EXRC MBT 018/UL1 17T 4A
• D78824114D00201: EXRC MBT 018/UR4&5 -7T 0A HK
• D78824113D00201: EXRC MBT 018/UR3 -7T 8A HK
• D78824112000201: EXRC MBT 018/UR2 10T 8A
• D78824111000201: EXRC MBT 018/UR1 17T 4A
• D78821541000101: EXP Mini TGO 020X028/LR1&2-1T 2A 0O
• D78821531000101: EXP Mini TGO 020X028 LL1&2-1T 2A 0O
• D78821522000101: EXPERIENCE Mini TGO 020X028/UL2 8T 9A
• D78821521000101: EXPERIENCE Mini TGO 020X028/UL1 12T 5A
• D78821512000101: EXPERIENCE Mini TGO 020X028/UR2 8T 9A
• D78821511000101: EXMP TGO 020X028/UR1 12T 5A
• D78821461000201: EXMP MBT 022/L1&2 -6T 0A
• D78821445D00201: EXMP MBT 022/LR5 -17T 2A HK
• D78821445D00101: EXMP ROTH 022/LR5 -22T -1A 4D HK
• D78821445000101: EXMP ROTH 022/LR5 -22T -1A 4D
• D78821444D00201: EXMP MBT 022/LR4 -12T 2A HK
• D78821444D00101: EXMP ROTH 022/LR4 -17T-1A 4D HK
• D78821444000101: EXMP ROTH 022/LR4 -17T -1A 4D