StoneBite® Introduction Package D504872A

GUDID E239D504872A1

No.

Dreve Dentamid GmbH

Bite registration rim wax

• Primary Device ID: E239D504872A1
• NIH Device Record Key: c6c246f0-f3e6-4927-bbd6-cb6fd4da2709
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StoneBite® Introduction Package
• Version Model Number: D504872A
• Catalog Number: D504872A
• 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
• Phone: +49230388070
• Email: info@dreve.de
• Phone: +49230388070
• Email: info@dreve.de
• Phone: +49230388070
• Email: info@dreve.de
• Phone: +49230388070
• Email: info@dreve.de
• Phone: +49230388070
• Email: info@dreve.de
• Phone: +49230388070
• Email: info@dreve.de
• Phone: +49230388070
• Email: info@dreve.de
• Phone: +49230388070
• Email: info@dreve.de
• Phone: +49230388070
• Email: info@dreve.de
• Phone: +49230388070
• Email: info@dreve.de
• Phone: +49230388070
• Email: info@dreve.de
• Phone: +49230388070
• Email: info@dreve.de
• Phone: +49230388070
• Email: info@dreve.de
• Phone: +49230388070
• Email: info@dreve.de
• Phone: +49230388070
• Email: info@dreve.de

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E239D504872A1 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-28
• Device Publish Date: 2021-10-20

Devices Manufactured by Dreve Dentamid GmbH

• E239D4248X7SQ1 - Drufosoft®: 2025-04-08 No.
• E239D4248X8S1 - Drufosoft®: 2025-04-08 No.
• E239D4248X8SQ1 - Drufosoft®: 2025-04-08 No.
• E239D4248X9S1 - Drufosoft®: 2025-04-08 No.
• E239D424901S1 - Drufosoft®: 2025-04-08 No.
• E239D424901SQ1 - Drufosoft®: 2025-04-08 No.
• E239D42531S1 - Drufosoft®: 2025-04-08 No.
• E239D4300S1 - BioBleach® soft: 2025-04-08 No.