Herbst

GUDID J01854781

Hinge system acc. to Herbst without fastening elements, 1 pair of hinges

Scheu-Dental GmbH

Orthodontic power arm

• Primary Device ID: J01854781
• NIH Device Record Key: 129aa069-26e4-4436-92a4-b03638aa2d62
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Herbst
• Version Model Number: 5478.1
• Company DUNS: 317683787
• Company Name: Scheu-Dental 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J01854781 [Primary]

FDA Product Code

• DYJ: Retainer, Screw Expansion, Orthodontic

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: 2024-11-27
• Device Publish Date: 2024-11-19

On-Brand Devices [Herbst]

• J01854801: Hinge system acc. to Herbst with slotted screws, 1 pair 1 pair of hinges and 4 pairs of fastenin
• J01854791: Hinge system acc. to Herbst with hexagon socket screws, 1 pair of hinges and 4 pairs of fasteni
• J01854781: Hinge system acc. to Herbst without fastening elements, 1 pair of hinges
• J01854560: Fastening elements for Herbst appliance with slotted screws, 4 pairs 4 pairs of fastening elemen
• J01854550: Fastening elements for Herbst appliance with hexagon socket screws, 4 pairs 4 pairs of fastening