Lamina Porcelain 6955

GUDID E23569550

Lamina Porcelain 15g LM B

SHOFU DENTAL CORPORATION

Dental appliance fabrication material, ceramic

• Primary Device ID: E23569550
• NIH Device Record Key: d5524235-6dba-4793-887e-582600fceb44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lamina Porcelain
• Version Model Number: 6955
• Catalog Number: 6955
• 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	E23569550 [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 [Lamina Porcelain]

• E23569560: Lamina Porcelain 15g LM D
• E23569550: Lamina Porcelain 15g LM B
• E23569540: Lamina Porcelain 15g LM A
• E23569530: Lamina Porcelain 15g LM A
• E23569520: Lamina Porcelain 15g LM A
• E23569510: Lamina Porcelain 15g LM A