ADSEAL Plus
FDA 510(k) K230010 · Meta Biomed Co., Ltd.
510(k) numberK230010
Submission
- Device name
- ADSEAL Plus
- Applicant
- Meta Biomed Co., Ltd.
Cheongju-Si, KR - Received
- January 3, 2023
- Decision date
- April 13, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code KIF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
More from Voco GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K242014 | Jet Flow BulkEBF · Traditional | 10/08/2024SE |
| K232299 | CeraPuttyKIF · Traditional | 09/29/2023SE |
| K230009 | EZ Bond UniversalKLE · Traditional | 03/03/2023SE |
| K210904 | Metapaste PlusKIF · Traditional | 06/30/2021SE |
| 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 ADSEAL Plus cleared by the FDA?
ADSEAL Plus (K230010) received a 510(k) decision of Substantially Equivalent on April 13, 2023, 100 days after the submission was received.
What is the product code of K230010?
The FDA product code is KIF – Resin, Root Canal Filling, a Class II (moderate risk) device regulated under 21 CFR 872.3820.