LEGEND 31-2GP5-10946

GUDID D788312GP5109461

LMI MBT 022 GP UL 3-3, UL 6-6, HK 3,4,5

Gc Orthodontics America Inc.

Orthodontic bracket, metal

• Primary Device ID: D788312GP5109461
• NIH Device Record Key: bd3da9c8-10e6-4e65-8fcd-9f35da20f331
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LEGEND
• Version Model Number: 31-2GP5-10946
• Catalog Number: 31-2GP5-10946
• 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	D788312GP5109461 [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 [LEGEND]

• D78838261000200: LEGEND LMIRC 022 L1&2 -6°T 0°A
• D78838255000200: LEGEND LMIRC 022 U5 -7°T 0°A
• D78838254000200: LEGEND LMIRC 022 U4 -7°T 0°A
• D78838245D00200: LEGEND LMIRC 022 LR5 -17°T 2°A HK
• D78838245000200: LEGEND LMIRC 022 LR5 -17°T 2°A
• D78838244D00200: LEGEND LMIRC 022 LR4 -12°T 2°A HK
• D78838244000200: LEGEND LMIRC 022 LR4 -12°T 2°A
• D78838243D00200: LEGEND LMIRC 022 LR3 -6°T 3°A HK
• D78838235D00200: LEGEND LMIRC 022 LL5 -17°T 2°A HK
• D78838235000200: LEGEND LMIRC 022 LL5 -17°T 2°A
• D78838234D00200: LEGEND LMIRC 022 LL4 -12°T 2°A HK
• D78838234000200: LEGEND LMIRC 022 LL4 -12°T 2°A
• D78838233D00200: LEGEND LMIRC 022 LL3 -7°T 9°A HK
• D78838224D00200: LEGEND LMIRC 022 UL4/5 -7°T 0°A HK
• D78838223D00200: LEGEND LMIRC 022 UL3 -7°T 9°A HK
• D78838222000200: LEGEND LMIRC 022 UL2 8°T 9°A
• D78838221000200: LEGEND LMIRC 022 UL1 17°T 4°A
• D78838214D00200: LEGEND LMIRC 022 UR4/5 -7°T 0°A HK
• D78838213D00200: LEGEND LMIRC 022 UR3 -7°T 9°A HK
• D78838212000200: LEGEND LMIRC 022 UR2 8°T 9°A
• D78838211000200: LEGEND LMI RC 022 UR1 17°T 4°A
• D78838161000200: LEGEND lLMI RC MBT 018/L1&2-6°T 0°A
• D78838155000200: LEGEND LMI RC 018/UR/UL4/5 -7°T 0°A
• D78838154000200: LEGEND LMI RC MBT 018/UR/UL4/5 -7°T
• D78838145D00200: LEGEND LMI RC MBT 018/LR5 -17°T 2°A HK
• D78838145000200: LEGEND LMI RC MBT 018/LR5 -17°T 2°A
• D78838144D00200: LEGEND LMI RC MBT 018/LR4 -12°T 2°A HK
• D78838144000200: LEGEND LMI RC MBT 018/LR4 -12°T 2°A
• D78838143D00200: LEGEND LMI RC MBT 018/LR3 -6°T 3°A 0OF HK
• D78838135D00200: LEGEND LMI RC MBT 018/LL5 -17T 2°A HK
• D78838135000200: LEGEND LMI RC MBT 018/LL5 -17°T 2°A
• D78838134D00200: LEGEND LMI RC MBT 018/LL4 -12T 2°A HK
• D78838134000200: LEGEND LMI RC MBT 018/LL4 -12°T 2°A
• D78838133D00200: LEGEND LMI RC MBT 018/LL3 -6°T 3°A 0OF HK
• D78838124D00200: LEGEND LMIRC 018 MBT UL4 -7°T 0°A HK
• D78838123D00200: LEGEND LMIRC 018 MBT UL3 -7°T 8°A HK
• D78838122000200: LEGEND LMIRC 018 MBT UL2 10°T 8°A
• D78838121000200: LEGEND LMIRC 018 MBT UL1 17°T 4°A
• D78838114D00200: LEGEND LMIRC 018 MBT UR4 -7°T 0°A HK
• D78838113D00200: LEGEND LMIRC 018 MBT UR3 -7°T 8°A HK
• D78838112000200: LEGEND LMIRC 018 MBT UR2 10°T 8°A
• D78838111000200: LEGEND LMIRC 018 MBT UR1 17°T 4°A
• D78832X5441: LEGEND MED VS 022 HK3 707
• D78832X29911: LEGEND LMED ROTH 018 HK 3,4,5
• D78832S19911: LEGEND MED HK34&5OB/LHK34&5OB
• D78832LMI221: LEGEND MED 022 MBT with LMI 2-2 HK3,4,5
• D78832BID300341: LEGEND LME BID VSLOT 018/022/U5-5/L5-5, 3HK
• D788322CC500201: LEGEND MEDIUM 022 MBT U5-5/L5-5 HK345
• D788322CC500101: LEGEND MEDIUM 022 ROTH U5-5/L5-5 HK345
• D788322CC400201: LEGEND LME MBT 022 U/L5-5 HK3,4