Vintage 6177

GUDID E23561770

Vintage Opaque 50g D2O

SHOFU DENTAL CORPORATION

Dental appliance fabrication material, ceramic

• Primary Device ID: E23561770
• NIH Device Record Key: 945c4cca-fc9b-4542-b6c7-6ce0e2be24b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vintage
• Version Model Number: 6177
• Catalog Number: 6177
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E23561770 [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: 2016-09-26

On-Brand Devices [Vintage]

• E23596150: VINTAGE MARGIN HARDENING LIQ 5
• E23596130: VINTAGE MIXING LIQUID-HC 50ml
• E23596110: VINTAGE MIXING LIQUID 50ml
• E23580120: VINTAGE MARGIN ISOLATION 1pc
• E23576420: HALO MARGIN PORCELAIN CPM LIQUID
• E23576400: HALO MARGIN PORCELAIN ISOLATION
• E23570180: Vintage Paint Opaque Liq. 350M
• E23570170: VINTAGE PAINT OPAQUE LIQ. 50ML
• E23570150: HALO MODEL LIQ.-L 500 ML
• E23570140: HALO MODEL LIQ.-L 50ML
• E23568870: Vintage Value Plus 50g VOP
• E23568860: Vintage Value Plus 15g VOP
• E23568820: Vintage Value Plus 50g VDL
• E23568810: Vintage Value Plus 15g VDL
• E23568720: Vintage Value Plus 50g VD3
• E23568710: Vintage Value Plus 15g VD3
• E23568620: Vintage Value Plus 50g VC4
• E23568610: Vintage Value Plus 15g VC4
• E23568520: Vintage Value Plus 50g VC2
• E23568510: Vintage Value Plus 15g VC2
• E23568420: Vintage Value Plus 50g VB4
• E23568410: Vintage Value Plus 15g VB4
• E23568370: Vintage Value Plus 50g VB3
• E23568360: Vintage Value Plus 15g VB3
• E23568320: Vintage Value Plus 50g VB2
• E23568310: Vintage Value Plus 15g VB2
• E23568270: Vintage Value Plus 50g VB1
• E23568260: Vintage Value Plus 15g VB1
• E23568220: Vintage Value Plus 50g VA4
• E23568170: Vintage Value Plus 50g VA3.5
• E23568160: Vintage Value Plus 15g VA3.5
• E23568120: Vintage Value Plus 50g VA3
• E23568110: Vintage Value Plus 15g VA3
• E23568070: Vintage Value Plus 50g VA2
• E23568060: Vintage Value Plus 15g VA2
• E23568020: Vintage Value Plus 50g VA1
• E23568010: Vintage Value Plus 15g VA1
• E23565070: Anti-greening Body 50ml
• E23565050: Anti-greening Opaque 50ml
• E23565020: Vintage Opaque Liquid 500ml
• E23565010: Vintage Opaque Liquid 50ml
• E23564920: Vintage Add on B 15g
• E23564910: Vintage Add on T 15g
• E23564870: Vintage Opal Milky 50g
• E23564860: Vintage Opal Milky 15g
• E23564820: Vintage Opal White E 50g
• E23564810: Vintage Opal White 15g
• E23564770: Vintage Color 50g Dark Pink
• E23564760: Vintage Color 15g Dark Pink
• E23564720: Vintage Color 50g Pink