Identity
- Trade Name
- OneBite Evolution FDA UDI
- Generic Name
- Facebow FDA UDI
- Device Name
- Midline Bar - Clinician Kit FDA UDI
- Model / Reference
- OBEV1007 FDA UDI
- Description
- Midline Bar - Clinician Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10850031761169 FDA UDI
- FDA Product Code
- EHY FDA UDI
- GMDN Term
- Facebow FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6880 FDA UDI
- Commercial Distribution
- 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
No
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
Category: Facebow
OneBite Evolution by Precision Dental Products, Llc — 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
- Precision Dental Products, Llc
Sources (1)
- FDA UDI 86167c11-f3e1-4ce4-84ba-c43c5f8b5010 34 fields · synced Jun 1, 2026