FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa)
K Number: K212254
·
Decision Oct 19, 2021
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
133
Applicant Total
9
Review Days
92
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Basic Information
- Device Name
- DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa)
- K Number
- K212254
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1750
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hdx Will Corp.
- Date Received
- July 19, 2021
- Decision Date
- October 19, 2021
- Product Code
- OAS
- Advisory Committee
- Radiology
- 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 |
|---|---|---|---|
| OAS | X-Ray, Tomography, Computed, Dental | FDA class 2 | Radiology |
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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 |
| K192700 | Xcam | Dec 27, 2019 | 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 |