PorcelEtch 661101

GUDID D7796611010

COSMEDENT, INC.

Dental etching solution Dental etching solution

• Primary Device ID: D7796611010
• NIH Device Record Key: bcf96155-074c-4432-85a6-874512a7dae8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PorcelEtch
• Version Model Number: 661101
• Catalog Number: 661101
• Company DUNS: 113911689
• Company Name: COSMEDENT, INC.
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D7796611010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K854494

FDA Product Code

• EBC: Sealant, Pit And Fissure, And Conditioner

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-22

On-Brand Devices [PorcelEtch]

• D7796631040: 663104
• D7796631020: 663102
• D7796631010: 663101
• D7796611010: 661101