Identity
- Trade Name
- Herbst FDA UDI
- Generic Name
- Orthodontic power arm FDA UDI
- Device Name
- Hinge system acc. to Herbst with hexagon socket screws, 1 pair of hinges and 4 pairs of fastening elements incl. hexagon socket screws FDA UDI
- Model / Reference
- 5479.1 FDA UDI
- Description
- Hinge system acc. to Herbst with hexagon socket screws, 1 pair of hinges and 4 pairs of fastening elements incl. hexagon socket screws FDA UDI
Identifiers
- Primary DI / UDI-DI
- J01854791 FDA UDI
- FDA Product Code
- DYJ FDA UDI
- GMDN Term
- Orthodontic power arm FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.5410 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthodontic power arm
Herbst by Scheu-Dental — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Scheu-Dental
Sources (1)
- FDA UDI cf002478-5b0b-4df5-b33f-1d38faced9d9 33 fields · synced May 30, 2026