Chic 14-243D-0010

GUDID D78814243D00101

CHIC ROTH 022/LR3 -11T 7A 2M HK

Gc Orthodontics America Inc.

Orthodontic bracket, ceramic

• Primary Device ID: D78814243D00101
• NIH Device Record Key: 3a38dee5-6113-4dd7-8f44-aae31ad1f6dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Chic
• Version Model Number: 14-243D-0010
• Catalog Number: 14-243D-0010
• 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	D78814243D00100 [Unit of Use]
HIBCC	D78814243D00101 [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 [Chic]

• D788142EE300101: CHIC ROTH 022/U3-3/L3-3, 3HK
• D788142E0300201: CHIC MBT 022/U3-3, 3HK
• D788142E0300101: CHIC ROTH 022/U3-3, 3HK
• D788142CE500201: CHIC MBT 022/U5-5/L3-3, 3,4,5HK
• D788142CE500101: Chic ROTH 022/U5-5/L3-3, 3,4,5HK
• D788142CE300201: CHIC MBT 022/U5-5/L3-3, 3HK
• D788142CE300101: Chic ROTH 022/U5-5/L3-3, 3HK
• D788142CC3SK011: CHIC/LMI ROTH 022/U5-5/L5-5 SK
• D788142C0500201: CHIC MBT 022/U5-5, 3,4,5HK
• D788142C0500101: Chic ROTH 022/U5-5, 3,4,5HK
• D788142C0300201: CHIC MBT 022/U5-5, 3HK
• D788142C0300101: Chic ROTH 022/U5-5, 3HK
• D78814265000201: CHIC MBT 022/L5 -17T 0A 0D
• D78814265000101: CHIC ROTH 022/L5 -22T 0A 0D
• D78814264000201: CHIC MBT 022/L4 -12T 0A 0D
• D78814264000101: CHIC ROTH 022/L4 -17T 0A 0D
• D78814261000201: CHIC MBT 022/L1&2 -6T 0A
• D78814261000101: CHIC ROTH 022/L1&2 0T 0A
• D78814255U00201: CHIC MBT 022/U5 -7T 0A 0D HK
• D78814255000201: CHIC MBT 022/U5 -7T 0A 0D
• D78814254U00201: CHIC MBT 022/U4&5 -7T 0A 0D HK
• D78814254U00101: CHIC ROTH 022/U4&5 -7T 0A 0D HK
• D78814254000201: CHIC MBT 022/U4&5 -7T 0A 0D
• D78814254000101: CHIC ROTH 022/U4&5 -7T 0A 0D
• D78814245D00201: CHIC MBT 022/LR5 -17T 0A 0D HK
• D78814245D00101: CHIC ROTH 022/LR5 -22T 0A 0D HK
• D78814244D00201: CHIC MBT 022/LR4 -12T 0A 0D HK
• D78814244D00101: CHIC ROTH 022/LR4 -17T 0A 0D HK
• D78814243D00201: CHIC MBT 022/LR3 -6T 3A HK
• D78814243D00101: CHIC ROTH 022/LR3 -11T 7A 2M HK
• D78814243000101: CHIC ROTH 022/LR3 -11T 7A 2M
• D78814235D00201: CHIC MBT 022/LL5 -17T 0A 0D HK
• D78814235D00101: CHIC ROTH 022/LL5 -22T 0A 0D HK
• D78814234D00201: CHIC MBT 022/LL4 -12T 0A 0D HK
• D78814234D00101: CHIC ROTH 022/LL4 -17T 0A 0D HK
• D78814233D00201: CHIC MBT 022/LL3 -6T 3A HK
• D78814233D00101: CHIC ROTH 022/LL3 -11T 7A 2M HK
• D78814233000101: CHIC ROTH 022/LL3 -11T 7A 2M
• D78814223D00201: CHC MBT 022/UL3 -7T 8A HK
• D78814223D00101: CHIC ROTH 022/UL3 -2T 13A 4M HK
• D78814223000101: CHIC ROTH 022/UL3 -2T 13A 4M
• D78814222000201: CHIC MBT 022/UL2 10T 8A
• D78814222000101: CHIC ROTH 022/UL2 8T 9A 0OF
• D78814221000201: CHIC MBT 022/UL1 17T 4A
• D78814221000101: CHIC ROTH 022/UL1 12T 5A 0OF
• D78814213D00201: CHIC MBT 022/UR3 -7T 8A HK
• D78814213D00101: CHIC ROTH 022/UR3 -2T 13A 4M HK
• D78814213000101: CHIC ROTH 022/UR3 -2T 13A 4M
• D78814212000201: CHIC MBT 022/UR2 10T 8A
• D78814212000101: CHIC ROTH 022/UR2 8T 9A 0OF