Permaflex FIX4

GUDID D814FIX41

Permaflex Glaze and Catalyst

PROTECH PROFESSIONAL PRODUCTS INC

Denture reliner, elastic, short-term

• Primary Device ID: D814FIX41
• NIH Device Record Key: 08ea3ff0-8f1e-4b47-b14e-f842d2e03f75
• Commercial Distribution Discontinuation: 2016-10-27
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Permaflex
• Version Model Number: FIX4
• Catalog Number: FIX4
• Company DUNS: 117374900
• Company Name: PROTECH PROFESSIONAL PRODUCTS 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D814FIX41 [Primary]

FDA Product Code

• EBI: Resin, Denture, Relining, Repairing, Rebasing

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: 2019-05-20
• Device Publish Date: 2016-08-31

On-Brand Devices [Permaflex]

• D814SIL21: 70 gram Permaflex relining material
• D814SIL11: Permaflex full kit - 70 g permaflex relining material, Adhesion promotor and glaze and catalyst
• D814FIX41: Permaflex Glaze and Catalyst