EXCALIBUR 11-2D04-0010

GUDID D788112D0400101

EXC ROTH 022 U 4-4 HK 34

Gc Orthodontics America Inc.

Orthodontic bracket, ceramic

• Primary Device ID: D788112D0400101
• NIH Device Record Key: 38b0adc7-f836-48cf-9d34-9f7053d1f95f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXCALIBUR
• Version Model Number: 11-2D04-0010
• Catalog Number: 11-2D04-0010
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D788112D0400101 [Primary]

FDA Product Code

• NJM: Bracket, ceramic, 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: 2022-11-15
• Device Publish Date: 2022-11-07

On-Brand Devices [EXCALIBUR]

• D788550FU200001: TN 3 Instrument
• D788GCO70011: WIRE CUTTER
• D788GCO3471: POSTERIOR BAND REMOVER
• D788GCO1581: WEINGART
• D788GCO1016U1: DISTAL END CUTTER
• D788GCO1016LH1: DISTAL END CUTTER MINI LONG HANDLE
• D788GCO1000HWC1: HARDWIRE CUTTER
• D788GCO10001: 15 DEGREE PIN & LIG
• D788GC1016SH1: DISTAL END CUTTER MINI LONG HANDLE
• D788GCO826301: Distal Thermo Plier
• D788GCO826201: Small Circle Forming Plier
• D788GCO825301: Mandibular Thermoforming Plier
• D788GCO825201: Maxillary Thermoforming Plier
• D788GCO825101: Undercut Enchancer Plier
• D788550FU300001: BEAVER TAIL
• D788GCO5151: SMAHA 515 FORCEP
• D788GCO346RT1: GCO-346 RT
• D788GCO14051: Narrow Replacement Set for GCO-345
• D788GCO880021: BRACKET POSITIONER
• D788GCO5101: Force Module Instrument (ASPEL)
• D788GCO4001: Set Roncone Plier
• D788GCO1391: Bird Beak Plier
• D788GCO10021: Miniature Pin and Ligature Cutter
• D788GCO10011: Pin and Ligature Cutter
• D788112D0400101: EXC ROTH 022 U 4-4 HK 34