Identity
- Trade Name
- Hanau Earpiece Facebow FDA UDI
- Generic Name
- Facebow FDA UDI
- Device Name
- A facebow is a device intended for use in a dental diagnostic procedure to record the relative position of the mandible to the temporomandibular joints (TMJs) and/or to record the spatial relationship between the maxilla and mandible. This is a reusable device. FDA UDI
- Model / Reference
- 008824-000 FDA UDI
- Description
- A facebow is a device intended for use in a dental diagnostic procedure to record the relative position of the mandible to the temporomandibular joints (TMJs) and/or to record the spatial relationship between the maxilla and mandible. This is a reusable device. FDA UDI
Identifiers
- Catalog Number
- 008824-000 FDA UDI
- Primary DI / UDI-DI
- D0400088240001 FDA UDI
- FDA Product Code
- KCR FDA UDI
- GMDN Term
- Facebow FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3220 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Hanau Earpiece Facebow by Whip-Mix Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Whip-Mix Corp.
Sources (1)
- FDA UDI e5dc187c-2e28-4f46-b6ba-6a7ed811c15d 35 fields · synced Jun 8, 2026