Plaquit D38124US

GUDID E239D38124US1

No.

Dreve Dentamid GmbH

Dental restorative material varnish

• Primary Device ID: E239D38124US1
• NIH Device Record Key: 57cccc64-95a6-4980-97df-aacb24864a02
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Plaquit
• Version Model Number: D38124US
• Catalog Number: D38124US
• 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: 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
• 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 away from sunlight
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E239D38124US1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162408

FDA Product Code

• EBD: Coating, filling material, resin

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: 2024-04-24
• Device Publish Date: 2024-04-16

On-Brand Devices [Plaquit]

• E239D381241: No.
• E239D381231: No.
• E239D38124US1: No.
• E239D38123US1: No.