Tempit

GUDID 00817051021850

Tempit-E Temporary Filling & Sealing Material with Eugenol

CENTRIX, INC.

Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement

• Primary Device ID: 00817051021850
• NIH Device Record Key: 751d574f-1961-4bd7-91fd-afc23ac94e70
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tempit
• Version Model Number: 310031
• Company DUNS: 053707303
• Company Name: CENTRIX, 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817051021850 [Primary]

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: 2024-01-08
• Device Publish Date: 2023-12-29

On-Brand Devices [Tempit]

• 00817051020051: Tempit Essentials prefilled temporary filling material tips Kit
• 00817051020044: Tempit Ultra prefilled temporary filling material tips, 30
• 00817051020037: Tempit Ultra F prefilled temporary filling material tips, 30
• 00817051020020: Tempit L/C prefilled temporary filling material tips, 30
• 00817051020013: Tempit prefilled temporary filling material tips, 30
• 00817051021850: Tempit-E Temporary Filling & Sealing Material with Eugenol