Vintage Halo 6042

GUDID E23560420

Vintage Opaque Dentin OD B4 50

SHOFU DENTAL CORPORATION

Dental appliance fabrication material, ceramic

• Primary Device ID: E23560420
• NIH Device Record Key: a17f9c97-7eea-4779-8e03-eb2df16ae3ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vintage Halo
• Version Model Number: 6042
• Catalog Number: 6042
• 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	E23560420 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K884214

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: 2016-09-24

On-Brand Devices [Vintage Halo]

• E23579020: HALO VALUE MINUS 15G VMODROOTR
• E23579010: HALO VALUE MINUS 15G VMOD-R4
• E23579000: HALO VALUE MINUS 15G VMOD-R3.5
• 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
• E23577880: Vintage Halo Whitening 50g W3B
• E23577870: Vintage Halo Whitening 50g W2B
• E23577860: Vintage Halo Whitening 50g W1B
• E23577830: Vintage Halo Whitening 15g W3B
• E23577820: Vintage Halo Whitening 15g W2B
• E23577810: Vintage Halo Whitening 15g W1B
• E23577780: Vintage Halo Whitening 50g W30
• E23577770: Vintage Halo Whitening 50g W20
• E23577760: Vintage Halo Whitening 50g W10
• E23577730: Vintage Halo Whitening 15g W30
• E23577720: Vintage Halo Whitening 15g W20
• E23577710: Vintage Halo Whitening 15g W10
• E23577700: Vintage Halo Whitening Set
• E23577490: HALO OPAQUE DENTIN 50G OD-D4