BIOPLAST® Color black

GUDID J01834480

BIOPLAST® Color 3.0 x 125 mm, black

Scheu-Dental GmbH

Dental appliance fabrication material, thermoplastic

• Primary Device ID: J01834480
• NIH Device Record Key: 2cce16ba-4324-4d2e-b655-c113c469734e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOPLAST® Color black
• Version Model Number: 3448.1
• Company DUNS: 317683787
• Company Name: Scheu-Dental GmbH
• Device Count: 10
• 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 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J01834480 [Unit of Use]
HIBCC	J01834481 [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

Devices Manufactured by Scheu-Dental GmbH

• J01810170 - J-Clasp: 2024-11-27 J-Clasp Ø 0.8 mm
• J01810180 - J-Clasp: 2024-11-27 J-Clasp Ø 0.9 mm
• J01810190 - J-Clasp: 2024-11-27 J-Clasp Ø 1.0 mm
• J01810201 - J-Clasp oblique: 2024-11-27 J-Clasp oblique Ø 0.8 mm, 10 pieces in pairs (5 left and 5 right)
• J01810210 - J-Clasp oblique: 2024-11-27 J-Clasp oblique Ø 0.9 mm, 100 pieces in pairs (50 left and 50 right)
• J01810220 - J-Clasp oblique: 2024-11-27 J-Clasp oblique Ø 1.0 mm, 100 pieces in pairs (50 left and 50 right)
• J01810230 - JM-Clasp: 2024-11-27 JM-Clasp Ø 1.2 mm
• J01810260 - T-Clasp: 2024-11-27 T-Clasp Ø 0.9 mm