Vintage Press Over 6091

GUDID E23560910

VINTAGE PRESS OVER PELLETS C2

SHOFU DENTAL CORPORATION

Dental appliance fabrication material, ceramic

• Primary Device ID: E23560910
• NIH Device Record Key: 6b64deda-da3c-469a-8d3c-d86fe005ad42
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vintage Press Over
• Version Model Number: 6091
• Catalog Number: 6091
• 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	E23560910 [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 Press Over]

• E23560910: VINTAGE PRESS OVER PELLETS C2
• E23560900: VINTAGE PRESS OVER PELLETS C1
• E23560820: VINTAGE PRESS OVER PELLETS A2
• E23560810: VINTAGE PRESS OVER PELLETS A1