FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
CleaniCal
K Number: K201799
·
Decision Feb 12, 2021
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
76
Applicant Total
8
Review Days
227
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Basic Information
- Device Name
- CleaniCal
- K Number
- K201799
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3250
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Maruchi
- Date Received
- June 30, 2020
- Decision Date
- February 12, 2021
- Product Code
- EJK
- 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 |
|---|---|---|---|
| EJK | Liner, Cavity, Calcium Hydroxide | FDA class 2 | Dental |
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Other Clearances by Maruchi
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|---|---|---|---|
| K213757 | Endocem MTA Premixed Regular | Feb 14, 2023 | Substantially Equivalent |
| K212229 | White Endoseal MTA | Aug 13, 2021 | Substantially Equivalent |
| K202015 | White ENDOSEAL MTA | Mar 24, 2021 | Substantially Equivalent |
| K170175 | ENDOSEAL MTA | Feb 26, 2018 | Substantially Equivalent |
| K133042 | ENDOCEM ZR | May 12, 2014 | Substantially Equivalent |
| K133054 | ENDOSEAL | May 12, 2014 | Substantially Equivalent |
| K112078 | ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE) | Mar 19, 2012 | Substantially Equivalent |