OBTURYS OBHM1-5

GUDID 03760260221085

ITENA CLINICAL

Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material

• Primary Device ID: 03760260221085
• NIH Device Record Key: 2e2b2c99-1a19-4b7c-b3fc-42c90c912046
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OBTURYS
• Version Model Number: Handmix
• Catalog Number: OBHM1-5
• Company DUNS: 278261221
• Company Name: ITENA CLINICAL
• 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: 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	03760260221085 [Primary]

FDA Product Code

• KIF: Resin, Root Canal Filling

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: 2022-11-10
• Device Publish Date: 2017-11-02

On-Brand Devices [OBTURYS]

• 03760260221214: Automix
• 03760260221092: Automix
• 03760260221085: Handmix