Identity
- Trade Name
- DENTRIα Series FDA UDI
- Generic Name
- Stationary panoramic/tomographic dental x-ray system, digital FDA UDI
- Device Name
- Device Description: DENTRIα Series is a dental CT, panoramic X-ray system, which is intended for dental radiographic examination and diagnosis of teeth, jaw and oral structures. FDA UDI
- Model / Reference
- DENTRIα FDA UDI
- Description
- Device Description: DENTRIα Series is a dental CT, panoramic X-ray system, which is intended for dental radiographic examination and diagnosis of teeth, jaw and oral structures. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800005200021 FDA UDI
- 510(k) Number
- K160140 FDA UDI
- FDA Product Code
- OAS FDA UDI
- GMDN Term
- Stationary panoramic/tomographic dental x-ray system, digital FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1750 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 panoramic/tomographic dental x-ray system, digital
DENTRIα Series by Hdx Will Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Stationary panoramic/tomographic dental x-ray system, digital.
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- Sleeve for extraoral X-Ray devices — Sirona Dental Systems GmbH · Class II
Cleared under the same submission
K160140 also covers:
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
- Hdx Will Corp.
Sources (1)
- FDA UDI 6ae6eaf3-c0d9-4393-a010-742a37b0469a 36 fields · synced Jun 1, 2026