Dynax® heavy body D6112

GUDID E239D61121

No.

Dreve Dentamid GmbH

Silicone dental impression material

• Primary Device ID: E239D61121
• NIH Device Record Key: f2457bd8-25c7-4f4a-9852-6d3dd377f000
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dynax® heavy body
• Version Model Number: D6112
• Catalog Number: D6112
• Company DUNS: 388000846
• Company Name: Dreve Dentamid 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: 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

Customer Support Contacts

• Phone: +49230388070
• Email: info@dreve.de

Operating and Storage Conditions

• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E239D61121 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171562

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: 2020-01-24
• Device Publish Date: 2018-04-18

On-Brand Devices [Dynax® heavy body]

• E239D61131: No.
• E239D61121: No.