FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
White Endoseal MTA
K Number: K212229
·
Decision Aug 13, 2021
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
142
Applicant Total
8
Review Days
28
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Basic Information
- Device Name
- White Endoseal MTA
- K Number
- K212229
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 872.3820
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Maruchi
- Date Received
- July 16, 2021
- Decision Date
- August 13, 2021
- Product Code
- KIF
- 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 |
|---|---|---|---|
| KIF | Resin, Root Canal Filling | FDA class 2 | Dental |
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Other Clearances by Maruchi
| K Number | Device Name | ||
|---|---|---|---|
| K213757 | Endocem MTA Premixed Regular | Feb 14, 2023 | Substantially Equivalent |
| K202015 | White ENDOSEAL MTA | Mar 24, 2021 | Substantially Equivalent |
| K201799 | CleaniCal | Feb 12, 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 |