PERK Emergency Denture Repair Kit

GUDID 00852305002117

A convenient collection of equipment and materials typically used in an emergency by a layperson to repair a damaged denture. It is available [non-prescription] over-the-counter (OTC) and enables the permanent repair of denture cracks and breaks without professional assistance. It typically consists of dental adhesive materials (e.g., a resin monomer system of powder and liquid glue) and mixing and application utensils. After application, this device cannot be reused.

PERMA LABORATORIES LLC

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• Primary Device ID: 00852305002117
• NIH Device Record Key: 03dda20b-600e-4d3e-8b17-9f06af2b752d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PERK Emergency Denture Repair Kit
• Version Model Number: pk6
• Company DUNS: 111780698
• Company Name: PERMA LABORATORIES LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852305002117 [Primary]

FDA Product Code

• EBO: Denture Repair Kit

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-07-16
• Device Publish Date: 2018-06-14

Devices Manufactured by PERMA LABORATORIES LLC

• 00852305002018 - ProSoft Professional Denture Reliner: 2018-08-09 A device consisting of a material such as plastic resin that is intended to be applied as a permanent coating or lining on the b
• 00852305002070 - Perma Soft Denture Reliner: 2018-08-09 A device consisting of a material such as plastic resin that is intended to be applied as a permanent coating or lining on the b
• 00852305002117 - PERK Emergency Denture Repair Kit: 2018-07-16A convenient collection of equipment and materials typically used in an emergency by a layperson to repair a damaged denture. It is available [non-prescription] over-the-counter (OTC) and enables the permanent repair of denture cracks and breaks without professional assistance. It typically consists of dental adhesive materials (e.g., a resin monomer system of powder and liquid glue) and mixing and application utensils. After application, this device cannot be reused.
• 00852305002117 - PERK Emergency Denture Repair Kit: 2018-07-16 A convenient collection of equipment and materials typically used in an emergency by a layperson to repair a damaged denture. It