Dentemp

GUDID 00372494101854

Dentemp is composed of zinc oxide-eugenol and intended as an over the counter temporary dental cement for re-cementing loose caps or crowns and replacing lost fillings.

Doc Brands, Inc.

Home-use dental cement

• Primary Device ID: 00372494101854
• NIH Device Record Key: b26ec790-ca10-4522-be5c-9d49bd699462
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dentemp
• 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 Dimensions

• Weight: 2.64 Gram
• Weight: 2.64 Gram
• Weight: 2.64 Gram
• Weight: 2.64 Gram
• Weight: 2.64 Gram
• Weight: 2.64 Gram
• Weight: 2.64 Gram
• Weight: 2.64 Gram
• Weight: 2.64 Gram
• Weight: 2.64 Gram
• Weight: 2.64 Gram
• Weight: 2.64 Gram
• Weight: 2.64 Gram

Device Identifiers

Device Issuing Agency	Device ID
GS1	00372494101854 [Primary]

FDA Product Code

• EMB: Zinc Oxide Eugenol

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.

• 00372494102271 - Dentemp Oral Care Kit: 2022-11-25 Dentemp Oral Care Kit contains the tools to keep that just from the dentist clean between dental visits. Safely and effectively
• 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: 2022-03-17Dentemp is composed of zinc oxide-eugenol and intended as an over the counter temporary dental cement for re-cementing loose caps or crowns and replacing lost fillings.
• 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: 2022-03-17 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