Identity
- Trade Name
- Acuity Direct X-Ray Photon Detection FDA UDI
- Generic Name
- Dental digital imaging sensor, intraoral FDA UDI
- Device Name
- An intraoral x-ray sensor that doesn't require a scintillator, but converts x-ray photons directly to a digital image. FDA UDI
- Model / Reference
- 005-00123 FDA UDI
- Description
- An intraoral x-ray sensor that doesn't require a scintillator, but converts x-ray photons directly to a digital image. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00872320006457 FDA UDI
- 510(k) Number
- K220277 FDA UDI
- FDA Product Code
- MUH FDA UDI
- GMDN Term
- Dental digital imaging sensor, intraoral 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: Dental digital imaging sensor, intraoral
Acuity Direct X-Ray Photon Detection by Cao Group, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental digital imaging sensor, intraoral.
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- XIOS XG SUPREME — SIRONA DENTAL, INC. · Class II
- SCHICK33 — SIRONA DENTAL, INC. · Class II
- XIOS XG WIFI — SIRONA DENTAL, INC. · Class II
Cleared under the same submission
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
- Cao Group, Inc.
Sources (1)
- FDA UDI 99e1a3a5-cedf-4636-b61f-e61ae55ad00b 35 fields · synced May 30, 2026