ProSoft Professional Denture Reliner

GUDID 00852305002018

A device consisting of a material such as plastic resin that is intended to be applied as a permanent coating or lining on the base or tissue-contacting surface of a denture for improved fitting. It is available [non-prescription] over-the-counter (OTC) and will enable the user to make a permanent adjustment without professional assistance. Denture relining is defined as a process of providing a new fitting surface to a denture (ISO 1942-2, def 2.111). After application, this device cannot be reused.

PERMA LABORATORIES LLC

Denture reliner, soft, home-use

• Primary Device ID: 00852305002018
• NIH Device Record Key: 698f4e6c-43b2-4bf0-a337-f1bda560f0ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProSoft Professional Denture Reliner
• Version Model Number: 2ps
• Company DUNS: 111780698
• Company Name: PERMA LABORATORIES LLC
• 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: 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

Customer Support Contacts

• Phone: 1-800-988-9194
• Email: permalabs@gmail.com
• Phone: 1-800-988-9194
• Email: permalabs@gmail.com
• Phone: 1-800-988-9194
• Email: permalabs@gmail.com
• Phone: 1-800-988-9194
• Email: permalabs@gmail.com
• Phone: 1-800-988-9194
• Email: permalabs@gmail.com
• Phone: 1-800-988-9194
• Email: permalabs@gmail.com
• Phone: 1-800-988-9194
• Email: permalabs@gmail.com
• Phone: 1-800-988-9194
• Email: permalabs@gmail.com
• Phone: 1-800-988-9194
• Email: permalabs@gmail.com
• Phone: 1-800-988-9194
• Email: permalabs@gmail.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852305002018 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121318

FDA Product Code

• EBP: Reliner, Denture, Over The Counter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-08-09
• Device Publish Date: 2018-06-14

Devices Manufactured by PERMA LABORATORIES LLC

• 00852305002018 - ProSoft Professional Denture Reliner: 2018-08-09A device consisting of a material such as plastic resin that is intended to be applied as a permanent coating or lining on the base or tissue-contacting surface of a denture for improved fitting. It is available [non-prescription] over-the-counter (OTC) and will enable the user to make a permanent adjustment without professional assistance. Denture relining is defined as a process of providing a new fitting surface to a denture (ISO 1942-2, def 2.111). After application, this device cannot be reused.
• 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: 2018-07-16 A convenient collection of equipment and materials typically used in an emergency by a layperson to repair a damaged denture. It