StoneBite® Introduction Package D504872A

GUDID E239D504872A1

No.

Dreve Dentamid GmbH

Bite registration rim wax Bite registration rim wax Bite registration rim wax Bite registration rim wax Bite registration rim wax Bite registration rim wax Bite registration rim wax Bite registration rim wax Bite registration rim wax Bite registration rim wax Bite registration rim wax Bite registration rim wax Bite registration rim wax Bite registration rim wax Bite registration rim wax 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

• E239D38123US1 - Plaquit: 2024-04-24 No.
• E239D38124US1 - Plaquit: 2024-04-24 No.
• E239D38900US1 - NanoVarnish: 2023-10-24 No.
• E239D3530011 - FotoDent® tray2: 2023-04-26 No.
• E239D3530021 - FotoDent® tray2: 2023-04-26 No.
• E239D3530031 - FotoDent® tray2: 2023-04-26 No.
• E239D38135N1 - Lightplast base plates: 2022-12-13 No.
• E239D38135R1 - Lightplast base plates: 2022-12-13 No.