FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Digital Dental Intra Oral Sensor, EzSensor Smart
K Number: K150797
·
Decision May 1, 2015
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
201
Applicant Total
16
Review Days
36
Basic Information
- Device Name
- Digital Dental Intra Oral Sensor, EzSensor Smart
- K Number
- K150797
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 872.1800
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Rayence Co., Ltd
- Date Received
- March 26, 2015
- Decision Date
- May 1, 2015
- 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
DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Rayence Co., Ltd
| K Number | Device Name | ||
|---|---|---|---|
| K243849 | 2430TCA with Xmaru W | Mar 12, 2025 | Substantially Equivalent |
| K242394 | Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF) | Sep 9, 2024 | Substantially Equivalent |
| K240371 | 0909FCC, 0909FCC-HS | Mar 7, 2024 | Substantially Equivalent |
| K231467 | 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF | Jun 21, 2023 | Substantially Equivalent |
| K212753 | 0909FCB, 1212FCA | Oct 18, 2021 | Substantially Equivalent |
| K202902 | 2430MCA with Xmaru W | Jun 21, 2021 | Substantially Equivalent |
| K210985 | 1717FCC | Apr 28, 2021 | Substantially Equivalent |
| K202722 | 1212FCA | Oct 26, 2020 | Substantially Equivalent |
| K190866 | XmaruView V1 (Xmaru Chiroview, Xmaru Podview) | Apr 30, 2019 | Substantially Equivalent |
| K171418 | 1417WCC_127um and1417WCC_140um | Jun 12, 2017 | Substantially Equivalent |