FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Root ZX3
K Number: K213477
·
Decision Aug 3, 2022
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
18
Applicant Total
52
Review Days
278
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Basic Information
- Device Name
- Root ZX3
- K Number
- K213477
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4920
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- J. Morita USA, Inc.
- Date Received
- October 29, 2021
- Decision Date
- August 3, 2022
- Product Code
- EKZ
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| EKZ | Unit, Electrosurgical, And Accessories, Dental | FDA class 2 | Dental |
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