Identity
- Trade Name
- DEXIS IXS Size 2 Sensor Kit FDA UDI
- Generic Name
- Dental digital imaging sensor, intraoral FDA UDI
- Model / Reference
- 1.013.2915 FDA UDI
Identifiers
- Primary DI / UDI-DI
- D090101329150 FDA UDI
- 510(k) Number
- K172918 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
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental digital imaging sensor, intraoral
DEXIS IXS Size 2 Sensor Kit by Dental Imaging Technologies Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K172918 also covers:
- DEXIS IXS S1 Warranty New — Dental Imaging Technologies Corporation
- DEXIS IXS S1 Warranty Replacement — Dental Imaging Technologies Corporation
- DEXIS IXS S2 Warranty New — Dental Imaging Technologies Corporation
- DEXIS IXS S2 Warranty Replacement — Dental Imaging Technologies Corporation
- DEXIS IXS Size 1 Sensor Kit — Dental Imaging Technologies Corporation
- DEXIS IXS Size 1 Sensor Kit — Dental Imaging Technologies Corporation
- DEXIS IXS Size 1 Sensor Kit — Dental Imaging Technologies Corporation
- DEXIS IXS Size 1 Sensor Kit — Dental Imaging Technologies Corporation
- DEXIS IXS Size 1, Intra-Oral X-Ray Sensor — Dental Imaging Technologies Corporation
- DEXIS IXS Size 2 Sensor Kit — Dental Imaging Technologies Corporation
- DEXIS IXS Size 2 Sensor Kit — Dental Imaging Technologies Corporation
- DEXIS IXS Size 2 Sensor Kit — Dental Imaging Technologies 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
- Dental Imaging Technologies Corporation
Sources (1)
- FDA UDI 9e206d0d-5984-4a50-945a-570bff5439af 33 fields · synced Jun 9, 2026