Tempit

GUDID 00817051020037

Tempit Ultra F prefilled temporary filling material tips, 30

CENTRIX, INC.

Dental crown/bridge, temporary Dental crown/bridge, temporary Dental crown/bridge, temporary Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge Temporary dental crown/bridge

• Primary Device ID: 00817051020037
• NIH Device Record Key: 72d33132-2719-446c-8823-63c51f78f979
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tempit
• Version Model Number: 310064
• 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	00817051020037 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K903551

FDA Product Code

• EBF: Material, Tooth Shade, Resin

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

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