Metapaste Plus
FDA 510(k) K210904 · Meta Biomed Co., Ltd.
510(k) numberK210904
Submission
- Device name
- Metapaste Plus
- Applicant
- Meta Biomed Co., Ltd.
Cheongju-Si, KR - Received
- March 26, 2021
- Decision date
- June 30, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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|---|---|---|---|
| K262050 | Vioseal XKIF · Traditional | Spident Co., Ltd. | 09/11/2026SE |
| K253909 | NeoPEX Pre-Mixed Obturation PasteKIF · Traditional | NuSmile, Ltd. | 09/04/2026SE |
| K261514 | Calcium Hydroxide Temporary Filling Material (KP-Cal)KIF · Traditional | Guilin Kevin Peter Technology Co., Ltd. | 08/25/2026SE |
| K261415 | Injectable Root Canal Sealer (KP-Root SP)KIF · Traditional | Guilin Kevin Peter Technology Co., Ltd. | 06/29/2026SE |
| K253167 | Any-PasteKIF · Traditional | Mediclus Co., Ltd. | 01/12/2026SE |
| K252890 | ZenSeal ProKIF · Traditional | Kerr Corporation | 01/07/2026SE |
| K251465 | Root canal repair materials (nRoot BP)KIF · Traditional | Enpuno Biotechnology Co., Ltd. | 09/25/2025SE |
| K252285 | Well-Root PTKIF · Traditional | Vericom Co., Ltd. | 09/19/2025SE |
| K251884 | One-Fil Putty InjectableKIF · Special | Mediclus Co., Ltd. | 08/22/2025SE |
| K251390 | MTA vptKIF · Traditional | Voco GmbH | 07/03/2025SE |
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|---|---|---|
| K242014 | Jet Flow BulkEBF · Traditional | 10/08/2024SE |
| K232299 | CeraPuttyKIF · Traditional | 09/29/2023SE |
| K230010 | ADSEAL PlusKIF · Traditional | 04/13/2023SE |
| K230009 | EZ Bond UniversalKLE · Traditional | 03/03/2023SE |
| K202617 | Metapex PlusKIF · Traditional | 04/14/2021SE |
| K191991 | EzfilEBF · Traditional | 03/05/2020SE |
| K190724 | MD-Temp PlusEBG · Traditional | 07/03/2019SE |
| K190503 | CeraSealKIF · Traditional | 06/07/2019SE |
| K190510 | GuttaSilKIF · Traditional | 05/29/2019SE |
| K181689 | NexcompEBF · Traditional | 11/15/2018SE |
Questions and answers
When was Metapaste Plus cleared by the FDA?
Metapaste Plus (K210904) received a 510(k) decision of Substantially Equivalent on June 30, 2021, 96 days after the submission was received.
What is the product code of K210904?
The FDA product code is KIF – Resin, Root Canal Filling, a Class II (moderate risk) device regulated under 21 CFR 872.3820.