StoneBite® scan D504870

GUDID E239D5048701

No.

Dreve Dentamid GmbH

Bite registration rim wax

• Primary Device ID: E239D5048701
• NIH Device Record Key: 38024476-71b8-4443-8c26-feb98104d8f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StoneBite® scan
• Version Model Number: D504870
• Catalog Number: D504870
• 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	E239D5048701 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190571

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: 6
• Public Version Date: 2019-11-28
• Device Publish Date: 2016-10-07

Devices Manufactured by Dreve Dentamid GmbH

• E239D420006SP1 - Biolon: 2025-02-28 No.
• E239D420008Q1 - Biolon: 2025-02-28 No.
• E239D420008S1 - Biolon: 2025-02-28 No.
• E239D420010Q1 - Biolon: 2025-02-28 No.
• E239D420002SP1 - Biolon: 2025-02-27 No.
• E239D420004Q1 - Biolon: 2025-02-27 No.
• E239D420004SP1 - Biolon: 2025-02-27 No.
• E239D420006Q1 - Biolon: 2025-02-27 No.