DURAN®+

GUDID J01834300

DURAN®+ 0.75 x 125 mm

Scheu-Dental GmbH

Dental appliance fabrication material, thermoplastic

• Primary Device ID: J01834300
• NIH Device Record Key: 958d9126-153a-4354-b323-12d29675e228
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DURAN®+
• Version Model Number: 3430.2
• Company DUNS: 317683787
• Company Name: Scheu-Dental GmbH
• Device Count: 100
• 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: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J01834300 [Unit of Use]
HIBCC	J01834301 [Primary]
HIBCC	J01834302 [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: 2024-11-26
• Device Publish Date: 2024-11-18

On-Brand Devices [DURAN®+]

• J01834850: DURAN®+ 1.0 x 114 x 499 mm strip
• J01834840: DURAN®+ 0.75 x 114 x 499 mm strip
• J01834830: DURAN®+ 0.625 x 114 x 499 mm strip
• J01834820: DURAN®+ 0.5 x 114 x 499 mm strip
• J01834720: DURAN®+ 0.4 x 125 mm
• J01834360: DURAN®+ 2.0 x 125 mm
• J01834340: DURAN®+ 1.5 x 125 mm
• J01834320: DURAN®+ 1.0 x 125 mm
• J01834300: DURAN®+ 0.75 x 125 mm
• J01834280: DURAN®+ 0.625 x 125 mm
• J01834260: DURAN®+ 0.5 x 125 mm