Refil-it

GUDID 00372494101885

Refilit is a Eugenol free temporary dental cement for replacing lost fillings.

Doc Brands, Inc.

Home-use dental cement

• Primary Device ID: 00372494101885
• NIH Device Record Key: 9a90a615-76ad-47d3-ba4a-09fc04480ab6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Refil-it
• Version Model Number: 1
• Company DUNS: 081254601
• Company Name: Doc Brands, 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: 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	00372494101885 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K964773

FDA Product Code

• EMA: Cement, Dental

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

Devices Manufactured by Doc Brands, Inc.

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• 00372494101250 - Dentemp Floss Picks: 2022-08-30 Dentemp Cool Mint-flavored Floss Picks are plastic handled flossing devices, with floss on one end and an interdental pick on th
• 00372494101700 - Recap-it: 2022-03-17 Recapit is a Eugenol free temporary dental cement for re-cementing loose caps or crowns.
• 00372494101854 - Dentemp: 2022-03-17 Dentemp is composed of zinc oxide-eugenol and intended as an over the counter temporary dental cement for re-cementing loose cap
• 00372494101885 - Refil-it: 2022-03-17Refilit is a Eugenol free temporary dental cement for replacing lost fillings.
• 00372494101885 - Refil-it: 2022-03-17 Refilit is a Eugenol free temporary dental cement for replacing lost fillings.
• 00372494101915 - Repair-it: 2022-03-17 Repair-it is an OTC denture repair kit for home use. The device consists of a material, such as a resin monomer system of powder
• 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