FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Xcam
K Number: K192700
·
Decision Dec 27, 2019
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
189
Applicant Total
9
Review Days
92
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Basic Information
- Device Name
- Xcam
- K Number
- K192700
- 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
- September 26, 2019
- Decision Date
- December 27, 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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Other Clearances by Hdx Will Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K211159 | eco-x Series (eco-x, eco-x-s) | Dec 30, 2021 | Substantially Equivalent |
| K211114 | Will3D | Dec 15, 2021 | Substantially Equivalent |
| K212254 | DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa) | Oct 19, 2021 | Substantially Equivalent |
| K190357 | Star-X, Intraoral X-ray System | Mar 15, 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 |