FOLIFLEX 1010120100

GUDID E23910101201001

No.

Dreve Dentamid GmbH

Dental appliance fabrication material, thermoplastic

• Primary Device ID: E23910101201001
• NIH Device Record Key: 2835df41-4b40-4c14-aa17-6fd3d2298f77
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FOLIFLEX
• Version Model Number: 1010120100
• Catalog Number: 1010120100
• 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
• 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

• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E23910101201001 [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: 2024-07-02
• Device Publish Date: 2024-06-24

On-Brand Devices [FOLIFLEX]

• E2391015SQ0501: No.
• E23910151250501: No.
• E23910151200501: No.
• E2391010SQ1001: No.
• E23910101251001: No.
• E23910101201001: No.
• E23910301250501: No.
• E23910301200501: No.
• E2391020SQ0501: No.
• E23910201250501: No.
• E23910201200501: No.
• E2391050SQ0501: No.
• E23910501250501: No.
• E23910501200501: No.
• E2391040SQ0501: No.
• E23910401250501: No.
• E23910401200501: No.
• E2391030SQ0501: No.