EXACTA Cement Xtra 1-7450

GUDID 00815619020468

EXACTA Cement Xtra 11g Syringe

EXACTA DENTAL PRODUCTS INC

Dental composite resin

• Primary Device ID: 00815619020468
• NIH Device Record Key: d48a4b94-8db4-4851-a394-62af405793e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXACTA Cement Xtra
• Version Model Number: 1-7450
• Catalog Number: 1-7450
• Company DUNS: 016325552
• Company Name: EXACTA DENTAL PRODUCTS 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	00815619020468 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102917

FDA Product Code

• EBG: Crown And Bridge, Temporary, 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 [EXACTA Cement Xtra]

• 00815619021175: EXACTA Cement Xtra 11g Syringe
• 00815619021168: EXACTA Cement Xtra 120g Cartridge
• 00815619020468: EXACTA Cement Xtra 11g Syringe
• 00815619020451: EXACTA Cement Xtra 120g Syringe