DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor
FDA 510(k) clearance K233053 · decided 2023-11-21
Clearance details
- K-number
- K233053
- Device name
- DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor
- Applicant
- Dental Imaging Technologies Corporation
- Decision
- Substantially Equivalent
- Date received
- 2023-09-25
- Decision date
- 2023-11-21
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- MUH
- Device class
- 2
- Regulation number
- 872.1800
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Quakertown, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.