O-Bite 999765

GUDID EDMG9997658

Bite registration material automix system. Fresh hardness for optimal occlusion. Content: 4 cartridges @50ml paste, Accessories

DMG Chemisch-Pharmazeutische Fabrik GmbH

Silicone dental impression material

• Primary Device ID: EDMG9997658
• NIH Device Record Key: 78df8e94-375d-4348-a40d-949c376b3530
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: O-Bite
• Version Model Number: 999765
• Catalog Number: 999765
• Company DUNS: 320744915
• Company Name: DMG Chemisch-Pharmazeutische Fabrik GmbH
• 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: true
• 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

Customer Support Contacts

• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EDMG9997650 [Primary]
HIBCC	EDMG9997651 [Package]; Contains: EDMG9997650; Package: [4 Units]; In Commercial Distribution
HIBCC	EDMG9997658 [Package]; Contains: EDMG9997651; Package: [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K810825

FDA Product Code

• ELW: Material, Impression

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: 2016-09-22

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