DEXIS IXS Size 1 Sensor Kit
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- DEXIS IXS S1 Kit EUDAMEDDEXIS IXS Size 1 Sensor Kit FDA UDI
- Generic Name
- Dental digital imaging sensor, intraoral FDA UDI
- Device Name
- DEXIS Titanium Intraoral X-Ray Sensor EUDAMED
- Model / Reference
- 1.013.9718 EUDAMEDFDA UDI1.012.6180 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D090101397180 EUDAMEDFDA UDI
- Basic UDI-DI
- ++D090Polaris5J EUDAMED
- 510(k) Number
- K172918 FDA UDI
- FDA Product Code
- MUH FDA UDI
- EMDN Code
- Z1103040102 EQUIPMENT FOR DIGITAL ENDORAL RADIOLOGY EUDAMED
- GMDN Term
- Dental digital imaging sensor, intraoral FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.1800 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Dental digital imaging sensor, intraoral
DEXIS IXS Size 1 Sensor Kit by Dental Imaging Technologies Corporation — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Dental digital imaging sensor, intraoral.
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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, 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
- DEXIS IXS Size 2 Sensor Kit — Dental Imaging Technologies Corporation
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Dental Imaging Technologies Corporation
Sources (2)
- FDA UDI d1716f38-15e6-4887-aa03-eb0bce3b3cda 33 fields · synced Jul 31, 2026
- EUDAMED d94204fa-7f74-499e-9d25-ef356dc8a2da 61 fields · synced Jul 31, 2026