Vintage Halo 7395

GUDID E23573950

HALO EFFECT COLOR 50G OM-YELLOW

SHOFU DENTAL CORPORATION

Dental appliance fabrication material, ceramic

• Primary Device ID: E23573950
• NIH Device Record Key: 6a884184-016c-40e4-987a-81ac24cd690e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vintage Halo
• Version Model Number: 7395
• Catalog Number: 7395
• Company DUNS: 054618202
• Company Name: SHOFU DENTAL CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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: 760-566-3528
• Email: ckaemmerlen@shofu.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E23573950 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K973247

FDA Product Code

• EIH: Powder, Porcelain

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-24
• Device Publish Date: 2016-09-25

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• E23578990: HALO VALUE MINUS 15G VMOD-R3
• E23578980: HALO VALUE MINUS 15G VMOD-R2
• E23578970: HALO VALUE MINUS 15G VMOD-R1
• E23578960: HALO VALUE MINUS 15G VMODROOTA
• E23578950: HALO VALUE MINUS 15G VMOD-A4
• E23578940: HALO VALUE MINUS 15G VMOD-A3.5
• E23578930: HALO VALUE MINUS 15G VMOD-A3
• E23578920: HALO VALUE MINUS 15G VMOD-A2
• E23578910: HALO VALUE MINUS 15G VMOD-A1
• E23578820: VM ROOT R BODY 15g
• E23578810: HALO VALUE MINUS 15G VMR4B
• E23578800: HALO VALUE MINUS 15G VMR3.5B
• E23578790: HALO VALUE MINUS 15G VMR3B
• E23578780: HALO VALUE MINUS 15G VMR2B
• E23578770: HALO VALUE MINUS 15G VMR1B
• E23578760: HALO VALUE MINUS 15G VMROOTAB
• E23578750: HALO VALUE MINUS 15G VMA4B
• E23578740: HALO VALUE MINUS 15G VMA3.5B
• E23578730: HALO VALUE MINUS 15G VMA3B
• E23578720: HALO VALUE MINUS 15G VMA2B
• E23578710: HALO VALUE MINUS 15G VMA1B
• E23578620: HALO VALUE MINUS 15G VMR R0
• E23578610: HALO VALUE MINUS 15G VMR4O
• E23578600: HALO VALUE MINUS 15G VMR3.5O
• E23578590: HALO VALUE MINUS 15G VMR3O
• E23578580: HALO VALUE MINUS 15G VMR2O
• E23578570: HALO VALUE MINUS 15G VMR1O
• E23578560: HALO VALUE MINUS 15G VMROOTAO
• E23578550: HALO VALUE MINUS 15G VMA4O
• E23578540: HALO VALUE MINUS 15G VMA3.5O
• E23578530: HALO VALUE MINUS 15G VMA3O
• E23578520: HALO VALUE MINUS 15G VMA20
• E23578510: HALO VALUE MINUS 15G VMA1O
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• E23577730: Vintage Halo Whitening 15g W30
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