DEXIS Ti2 Sensor Kit
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- DEXIS Ti2 Sensor EUDAMEDFDA UDIDEXIS Ti2 Sensor Kit FDA UDI
- Generic Name
- Dental digital imaging sensor, intraoral FDA UDI
- Device Name
- DEXIS Titanium Intraoral X-Ray Sensor EUDAMEDDEXIS Ti2 Warranty Replacement - R FDA UDI
- Model / Reference
- 8.000.2572 EUDAMEDFDA UDI1.012.6180 EUDAMED8.000.2580 FDA UDI
- Description
- DEXIS Ti2 Warranty Replacement - R FDA UDI
Identifiers
- Primary DI / UDI-DI
- D090800025720 EUDAMEDFDA UDID090800025800 FDA UDI
- Basic UDI-DI
- ++D090Polaris5J EUDAMED
- 510(k) Number
- K233053 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
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Dental digital imaging sensor, intraoral
DEXIS Ti2 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
K233053 also covers:
- DEXIS Ti2 Sensor - R — Dental Imaging Technologies Corporation
- DEXIS Ti2 Sensor Kit — Dental Imaging Technologies Corporation
- DEXIS Ti2 Sensor Kit — Dental Imaging Technologies Corporation
- DEXIS Ti2 Sensor Kit — Dental Imaging Technologies Corporation
- DEXIS Ti2 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 (3)
- FDA UDI 098adca9-e9f9-4f12-8611-b9ca298f455d 34 fields · synced Jun 20, 2026
- FDA UDI 815685cd-0723-4c6b-8fb2-89c91ebe1b68 33 fields · synced May 30, 2026
- EUDAMED 0124c413-e3a5-42b7-9ed2-0b0daf667f7d 61 fields · synced Jun 20, 2026