Reline-it

GUDID 00372494101960

The device is a temporary OTC soft, clear denture reliner consisting of 2 parts (1) a monomer liquid and (2) a polymer powder which are mixed together prior to application. This results in a plastic resin paste which is then applied to the denture plate and set in the mouth to cure for a short period of time. Once setting is complete, the excess soft material is able to be trimmed by an enclosed spatula. The application is completely reversible by soaking the denture plate overnight in an over the counter solution of hydrogen peroxide and then removing it by hand.

Doc Brands, Inc.

Denture reliner, soft, home-use

• Primary Device ID: 00372494101960
• NIH Device Record Key: 64adc820-430c-4a4c-9e7c-3c4409f88062
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reline-it
• Version Model Number: 1
• Company DUNS: 081254601
• Company Name: Doc Brands, Inc.
• 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: true
• 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: 833-362-2763
• Email: consumeraffairs@doc-brands.com
• Phone: 833-362-2763
• Email: consumeraffairs@doc-brands.com
• Phone: 833-362-2763
• Email: consumeraffairs@doc-brands.com
• Phone: 833-362-2763
• Email: consumeraffairs@doc-brands.com
• Phone: 833-362-2763
• Email: consumeraffairs@doc-brands.com
• Phone: 833-362-2763
• Email: consumeraffairs@doc-brands.com
• Phone: 833-362-2763
• Email: consumeraffairs@doc-brands.com
• Phone: 833-362-2763
• Email: consumeraffairs@doc-brands.com
• Phone: 833-362-2763
• Email: consumeraffairs@doc-brands.com
• Phone: 833-362-2763
• Email: consumeraffairs@doc-brands.com
• Phone: 833-362-2763
• Email: consumeraffairs@doc-brands.com
• Phone: 833-362-2763
• Email: consumeraffairs@doc-brands.com
• Phone: 833-362-2763
• Email: consumeraffairs@doc-brands.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00372494101960 [Primary]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-17
• Device Publish Date: 2022-03-09

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• 00372494101960 - Reline-it: 2022-03-17The device is a temporary OTC soft, clear denture reliner consisting of 2 parts (1) a monomer liquid and (2) a polymer powder which are mixed together prior to application. This results in a plastic resin paste which is then applied to the denture plate and set in the mouth to cure for a short period of time. Once setting is complete, the excess soft material is able to be trimmed by an enclosed spatula. The application is completely reversible by soaking the denture plate overnight in an over the counter solution of hydrogen peroxide and then removing it by hand.
• 00372494101960 - Reline-it: 2022-03-17 The device is a temporary OTC soft, clear denture reliner consisting of 2 parts (1) a monomer liquid and (2) a polymer powder wh
• 00816161015131 - Ora-GUARD: 2022-03-17 Ora-GUARD is an OTC device worn on the teeth while sleeping, intended to protect the teeth and reduce damage caused by bruxing o