Drufosoft® D4248X20

GUDID E239D4248X201

No.

Dreve Dentamid GmbH

Dental appliance fabrication material, thermoplastic

• Primary Device ID: E239D4248X201
• NIH Device Record Key: 69def1c5-3971-4d45-8c4a-509f92e7a509
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Drufosoft®
• Version Model Number: D4248X20
• Catalog Number: D4248X20
• 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	E239D4248X201 [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

On-Brand Devices [Drufosoft®]

• E239D42531SQ1: No.
• E239D425311: No.
• E239D4252SQ1: No.
• E239D42521: No.
• E239D42511SQ1: No.
• E239D42511S1: No.
• E239D42501: No.
• E239D4249011: No.
• E239D4248X9SQ1: No.
• E239D4248X91: No.
• E239D4248X81: No.
• E239D4248X71: No.
• E239D4248X6S1: No.
• E239D4248X61: No.
• E239D4248X51: No.
• E239D4248X41: No.
• E239D4248X3Q1: No.
• E239D4248X31: No.
• E239D4248X26SQ1: No.
• E239D4248X261: No.
• E239D4248X251: No.
• E239D4248X24S1: No.
• E239D4248X241: No.
• E239D4248X23SQ1: No.
• E239D4248X231: No.
• E239D4248X221: No.
• E239D4248X21SQ1: No.
• E239D4248X211: No.
• E239D4248X21: No.
• E239D4248X201: No.
• E239D4248X191: No.
• E239D4248X18SQ1: No.
• E239D4248X18S1: No.
• E239D4248X181: No.
• E239D4248X17SQ1: No.
• E239D4248X171: No.
• E239D42483X91: No.
• E239D42483X81: No.
• E239D42483X71: No.
• E239D42483X61: No.
• E239D42483X51: No.
• E239D42483X41: No.
• E239D42483X31: No.
• E239D42483X261: No.
• E239D42483X251: No.
• E239D42483X241: No.
• E239D42483X231: No.
• E239D42483X221: No.
• E239D42483X211: No.
• E239D42483X21: No.