DentaSonic 55-FDM0-5115

GUDID D78855FDM051150

DS DIASTRIP REFILL 1-SIDE 15 MM PK5

Gc Orthodontics America Inc.

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• Primary Device ID: D78855FDM051150
• NIH Device Record Key: b7f3e44e-fbf5-4dd9-b8fb-e786bdb29938
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DentaSonic
• Version Model Number: 55-FDM0-5115
• Catalog Number: 55-FDM0-5115
• Company DUNS: 063167128
• Company Name: Gc Orthodontics America Inc.
• Device Count: 5
• 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)897-5589
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-5589
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-5589
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-5589
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-5589
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-5589
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-5589
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-5589
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-5589
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-5589
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-5589
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-5589
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-5589
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-5589
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-5589
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-5589
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-5589
• Email: GCOAInfo@gcorthodontics.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D78855FDM051150 [Unit of Use]
HIBCC	D78855FDM051151 [Primary]

FDA Product Code

• EMI: FILE, BONE, SURGICAL

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 [DentaSonic]

• E53555SDM053400: DS DIASAW 0,12MM 2-SIDE 40 MICRON PK5
• E53555SDM053250: DS DIASAW 0,12MM 2-SIDE 25 MICRON PK5
• E53555SDM053150: DS DIASAW 0,12MM 2-SIDE 15 MICRON PK5
• E53555FDM051600: DS DIASTRIP REFILL 1-SIDE 60 MICRON PK5
• E53555FDM051400: DS DIASTRIP REFILL 1-SIDE 40 MICRON PK5
• E53555FDM051250: DS DIASTRIP REFILL 1-SIDE 25 MICRON PK5
• E53555FDM051150: DS DIASTRIP REFILL 1-SIDE 15 MICRON PK5
• E53555BD0200001: DS PROFI KIT 2 4:1 HP WATER COOLING
• E53555MD0000001: DS MICRO MOTOR PORTABLE
• D78855SDM053250: DS DIASAW 0,12MM 2-SIDE 25 MM PK5
• D78855SDM053150: DS DIASAW 0,12MM 2-SIDE 15 MM PK5
• D78855SDM053000: DS DIASAW ASSORTED 2-SIDE PK5
• D78855MD0000001: DS MICRO MOTOR PORTABLE
• D78855G00010000: DS MEASURING GAUGE 6 SIZES
• D78855FDML51600: DS DIASTRIP REFILL 1-SIDE LEFT .3mm PK5
• D78855FDML51250: DS DIASTRIP REFILL 1-SIDE LEFT .2mm PK5
• D78855FDML51150: DS DIASTRIP REFILL 1-SIDE LEFT .1mm PK5
• D78855FDM052600: DS DIASTRIP REFILL 2-SIDE 60 MM PK5
• D78855FDM052500: DS RESIN DIASTRIP 2 SIDED .5MM PK5
• D78855FDM052400: DS DIASTRIP REFILL 2-SIDE 40 MM PK5
• D78855FDM052250: DS DIASTRIP REFILL 2-SIDE 25 MM PK5
• D78855FDM052150: DS DIASTRIP REFILL 2-SIDE 15 MM PK5
• D78855FDM052000: DS DIASTRIP REFILL 1-SIDE 40 MM PK5
• D78855FDM051400: DS DIASTRIP ASSORTED 2-SIDE PK5
• D78855FDM051250: DS DIASTRIP REFILL 1-SIDE 25 MM PK5
• D78855FDM051150: DS DIASTRIP REFILL 1-SIDE 15 MM PK5
• D78855FDM012600: DS DIASTRIP REFILL 2-SIDE 60 MM PK12
• D78855FDM012400: DS DIASTRIP REFILL 2-SIDE 40 MM PK12
• D78855FDM012250: DS DIASTRIP REFILL 2-SIDE 25 MM PK12
• D78855FDM012150: DS DIASTRIP REFILL 2-SIDE 15 MM PK12
• D78855FDM012000: DS DIASTRIP ASSORTED 2-SIDE PK12
• D78855FD0A53000: DS DIASTRIP ALIGNER SET ASSORTED PK5
• D78855D0006B000: DS DEBONDING SET 2 SHAPES PK6
• D78855D00062000: DS DEBONDING REFILL POINT PK6
• D78855D00061000: DS DEBONDING REFILL CUP PK6
• D78855BEVO00001: DS Cordless Portable IPR Motor
• D78855BD0200001: DS PROFI KIT 2 4:1 HP WATER COOLING