Lightpaint on Surface D38239

GUDID E239D382391

No.

Dreve Dentamid GmbH

Dental restorative material varnish

• Primary Device ID: E239D382391
• NIH Device Record Key: 39f80373-9226-4c81-96aa-c9299752ac95
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lightpaint on Surface
• Version Model Number: D38239
• Catalog Number: D38239
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E239D382391 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-01-24
• Device Publish Date: 2018-04-12

Devices Manufactured by Dreve Dentamid GmbH

• E239D42451S1 - Drufosoft®: 2024-08-22 No.
• E239D42481S1 - Drufosoft®: 2024-08-22 No.
• E2391030SQ0501 - FOLIFLEX: 2024-07-04 No.
• E23910401200501 - FOLIFLEX: 2024-07-04 No.
• E23910401250501 - FOLIFLEX: 2024-07-04 No.
• E2391040SQ0501 - FOLIFLEX: 2024-07-04 No.
• E23910501200501 - FOLIFLEX: 2024-07-04 No.
• E23910501250501 - FOLIFLEX: 2024-07-04 No.