FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Star-X, Intraoral X-ray System
K Number: K190357
·
Decision Mar 15, 2019
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
189
Applicant Total
9
Review Days
28
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Basic Information
- Device Name
- Star-X, Intraoral X-ray System
- K Number
- K190357
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1800
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hdx Will Corp.
- Date Received
- February 15, 2019
- Decision Date
- March 15, 2019
- Product Code
- EHD
- 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 |
|---|---|---|---|
| EHD | Unit, X-Ray, Extraoral With Timer | FDA class 2 | Dental |
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| K192700 | Xcam | Dec 27, 2019 | Substantially Equivalent |
| K181297 | DENTIOIII series (DENTIOIII, DENTIOIII-S) | Nov 21, 2018 | Substantially Equivalent |
| K172168 | WillCeph | Mar 21, 2018 | Substantially Equivalent |
| K170180 | Will3D | May 8, 2017 | Substantially Equivalent |
| K160140 | DENTRIa series | Sep 30, 2016 | Substantially Equivalent |