Vintage AL/ZR 8011

GUDID E23580110

VINTAGE AL OPAQUE LINER LIQ 3m

SHOFU DENTAL CORPORATION

Dental appliance fabrication material, ceramic

• Primary Device ID: E23580110
• NIH Device Record Key: afb87996-e34e-4bf2-ba5a-aed7c361c188
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vintage AL/ZR
• Version Model Number: 8011
• Catalog Number: 8011
• 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	E23580110 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032165

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: 2016-09-23

Devices Manufactured by SHOFU DENTAL CORPORATION

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• 14548162335460 - ROBOT POINTS PRO-CUT: 2024-09-12 ROBOT POINTS PRO-CUT FG D006EF 5pcs
• 14548162335477 - ROBOT POINTS PRO-CUT: 2024-09-12 ROBOT POINTS PRO-CUT FG D007EF 5pcs
• 14548162335484 - ROBOT POINTS PRO-CUT: 2024-09-12 ROBOT POINTS PRO-CUT FG D010EF 5pcs
• 14548162335491 - ROBOT POINTS PRO-CUT: 2024-09-12 ROBOT POINTS PRO-CUT FG D027EF 5pcs
• 14548162335507 - ROBOT POINTS PRO-CUT: 2024-09-12 ROBOT POINTS PRO-CUT FG D053EF 5pcs
• 14548162335514 - ROBOT POINTS PRO-CUT: 2024-09-12 ROBOT POINTS PRO-CUT FG D054EF 5pcs
• 14548162335521 - ROBOT POINTS PRO-CUT: 2024-09-12 ROBOT POINTS PRO-CUT FG D055EF 5pcs