FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor
K Number: K233053
·
Decision Nov 21, 2023
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
201
Applicant Total
1
Review Days
57
Basic Information
- Device Name
- DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor
- K Number
- K233053
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1800
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dental Imaging Technologies Corporation
- Date Received
- September 25, 2023
- Decision Date
- November 21, 2023
- Product Code
- MUH
- Advisory Committee
- Dental
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MUH | System, X-Ray, Extraoral Source, Digital | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MUH), ordered by most recent decision date.
VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan)
FDA 510(k)
FDA Class 2
·Dental
X Sensor (Model: IOS-A15IF, HDI-15DGF)
FDA 510(k)
FDA Class 2
·Dental
DUO1 and DUO2
FDA 510(k)
FDA Class 2
·Dental
RAYSCAN a-Expert
FDA 510(k)
FDA Class 2
·Dental
Digital image scanner of dental
FDA 510(k)
FDA Class 2
·Dental
TuxDeluxe (Size 1 6100B, Size 2 6101B)
FDA 510(k)
FDA Class 2
·Dental