Identity
- Trade Name
- Midmark Vantage Cephalometric Sensor FDA UDI
- Generic Name
- Stationary cephalometric x-ray system, digital FDA UDI
- Device Name
- Panoramic X-ray CephalometricSensor Assembly FDA UDI
- Model / Reference
- 60-A1004 FDA UDI
- Description
- Panoramic X-ray CephalometricSensor Assembly FDA UDI
Identifiers
- Catalog Number
- 60-A1004 FDA UDI
- Primary DI / UDI-DI
- 00841709102547 FDA UDI
- 510(k) Number
- K122643 FDA UDI
- FDA Product Code
- MUH FDA UDI
- GMDN Term
- Stationary cephalometric x-ray system, digital FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.1800 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
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Stationary cephalometric x-ray system, digital
Midmark Vantage Cephalometric Sensor by Midmark Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K122643 also covers:
- Midmark Progeny Vantage Digital Panoramic System with Cephalometric Sensor — Midmark Corporation
- Midmark Progeny Vantage Digital Panoramic System with Cephalometric Sensor — Midmark Corporation
- Midmark Progeny Vantage Digital Panoramic System with Cephalometric Sensor — Midmark Corporation
- Midmark Progeny Vantage Digital Panoramic System with Cephalometric Sensor — Midmark Corporation
- Midmark Vantage Cephalometric Sensor — Midmark Corporation
- Midmark Vantage Cephalometric Sensor — Midmark Corporation
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 II | Pending data |
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Manufacturer
- Manufacturer
- Midmark Corporation
Sources (1)
- FDA UDI dcc44356-d166-4601-bc2b-e3d68200b930 37 fields · synced Jun 8, 2026