BioBleach® hart D420015

GUDID E239D4200151

No.

Dreve Dentamid GmbH

Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic

• Primary Device ID: E239D4200151
• NIH Device Record Key: d33bc0e0-f5f9-4509-ae22-8cc929948f09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioBleach® hart
• Version Model Number: D420015
• Catalog Number: D420015
• Company DUNS: 388000846
• Company Name: Dreve Dentamid GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: dentamid@dreve.de
• Phone: +49230388070
• Email: dentamid@dreve.de
• Phone: +49230388070
• Email: dentamid@dreve.de
• Phone: +49230388070
• Email: dentamid@dreve.de
• Phone: +49230388070
• Email: dentamid@dreve.de
• Phone: +49230388070
• Email: dentamid@dreve.de
• Phone: +49230388070
• Email: dentamid@dreve.de
• Phone: +49230388070
• Email: dentamid@dreve.de
• Phone: +49230388070
• Email: dentamid@dreve.de
• Phone: +49230388070
• Email: dentamid@dreve.de
• Phone: +49230388070
• Email: dentamid@dreve.de
• Phone: +49230388070
• Email: dentamid@dreve.de
• Phone: +49230388070
• Email: dentamid@dreve.de

Operating and Storage Conditions

• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E239D4200151 [Primary]

FDA Product Code

• KMY: POSITIONER, TOOTH, PREFORMED

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: 2022-08-29
• Device Publish Date: 2022-08-19

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.