LEGACY 28-245D-0010

GUDID D78828245D00101

ROTH 022/LR5-22T-1A 4D HK

Gc Orthodontics America Inc.

Orthodontic bracket, metal

• Primary Device ID: D78828245D00101
• NIH Device Record Key: 651f0ee3-811f-4415-82b1-213803b192c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LEGACY
• Version Model Number: 28-245D-0010
• Catalog Number: 28-245D-0010
• Company DUNS: 063167128
• Company Name: Gc Orthodontics America Inc.
• Device Count: 10
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D78828245D00100 [Unit of Use]
HIBCC	D78828245D00101 [Primary]

FDA Product Code

• EJF: BRACKET, METAL, 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: 2017-05-04

On-Brand Devices [LEGACY]

• D78828245D00101: ROTH 022/LR5-22T-1A 4D HK
• D78828245000101: ROTH 022/LR5-22T-1A 4D
• D78828244D00101: ROTH 022/LR4-17T-1A 4D HK
• D78828244000101: ROTH 022/LR4-17T-1A 4D
• D78828243D00111: ROTH XT 022/LR3 0T 5A HK
• D78828243D00101: ROTH 022/LR3-11T 7A 2M HK
• D78828243000101: ROTH 022/LR3-11T 7A 2M
• D78828241000101: ROTH 022/LR1&2-1T 2A
• D78828235D00101: ROTH 022/LL5-22T-1A 4D HK
• D78828235000101: ROTH 022/LL5-22T-1A 4D
• D78828234D00101: ROTH 022/LL4-17T-1A 4D HK
• D78828234000101: ROTH 022/LL4-17T-1A 4D
• D78828233D00111: ROTH XT 022/LL3 0T 5A HK
• D78828233D00101: ROTH 022/LL3-11T 7A 2M HK
• D78828233000101: ROTH 022/LL3-11T 7A 2M
• D78828231000101: ROTH 022/LL1&2-1T 2A
• D78828224M00101: ROTH 022/UL4-7T 0A 2D MHK
• D78828224D00101: ROTH 022/UL4-7T 0A 2D HK
• D78828224000101: ROTH 022/UL4&5-7T 0A 2D
• D78828223D00121: ROTH SP 022/UL3-2T 9A 4M H
• D78828223D00111: ROTH XT 022/UL3 3T 13A 4M H
• D78828223D00101: ROTH 022/UL3-2T 13A 4M HK
• D78828223000121: ROTH SP 022/UL3-2T 9A 4M
• D78828223000111: ROTH XT 022/UL3 3T 9A 4M
• D78828223000101: ROTH 022/UL3-2T 13A 4M
• D78828222D00101: ROTH 022/UL2 8T 9A HK
• D78828222000111: ROTH XT 022/UL2 10T 9A
• D78828222000101: ROTH 022/UL2 8T 9A
• D78828221000111: ROTH XT 022/UL1 17T 5A
• D78828221000101: ROTH 022/UL1 12T 5A
• D78828214M00101: ROTH 022/UR4-7T 0A 2D MHK
• D78828214D00101: ROTH 022/UR4-7T 0A 2D HK
• D78828214000101: ROTH 022/UR4&5-7T 0A 2D
• D78828213D00121: ROTH SP 022/UR3-2T 9A 4MHK
• D78828213D00111: ROTH XT 022/UR3 3T 13A 4MHK
• D78828213D00101: ROTH 022/UR3-2T 13A 4M HK
• D78828213000121: ROTH SP 022/UR3-2T 9A 4M
• D78828213000111: ROTH XT 022/UR3 3T 9A 4M
• D78828213000101: ROTH 022/UR3-2T 13A 4M
• D78828212D00101: ROTH 022/UR2 8T 9A HK
• D78828212000111: ROTH XT 022/UR2 10T 9A
• D78828212000101: ROTH 022/UR2 8T 9A
• D78828211000111: ROTH XT 022/UR1 17T 5A
• D78828211000101: ROTH 022/UR1 12T 5A
• D78828145000101: LG ROTH 018/LR5 -22T -1A 4D
• D78828144D00101: LG ROTH 018/LR4 -17T -1A 4D HK
• D78828144000101: LG ROTH 018/LR4 -17T -1A 4D
• D78828135000101: LG ROTH 018/LL5 -22T -1A 4D
• D78828134D00101: LG ROTH 018/LL4 -17T-1A 4D HK
• D78828134000101: LG ROTH 018/LL4 -17T-1A 4D