FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Metapaste Plus
K Number: K210904
·
Decision Jun 30, 2021
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
142
Applicant Total
21
Review Days
96
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Basic Information
- Device Name
- Metapaste Plus
- K Number
- K210904
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3820
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Meta Biomed Co., Ltd.
- Date Received
- March 26, 2021
- Decision Date
- June 30, 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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| K230009 | EZ Bond Universal | Mar 3, 2023 | Substantially Equivalent |
| K202617 | Metapex Plus | Apr 14, 2021 | Substantially Equivalent |
| K191991 | Ezfil | Mar 5, 2020 | Substantially Equivalent |
| K190724 | MD-Temp Plus | Jul 3, 2019 | Substantially Equivalent |
| K190503 | CeraSeal | Jun 7, 2019 | Substantially Equivalent |
| K190510 | GuttaSil | May 29, 2019 | Substantially Equivalent |
| K181689 | Nexcomp | Nov 15, 2018 | Substantially Equivalent |