Endocem MTA Premixed Regular
FDA 510(k) K213757 · Maruchi
510(k) numberK213757
Submission
- Device name
- Endocem MTA Premixed Regular
- Applicant
- Maruchi
Wonju-Si, KR - Received
- November 30, 2021
- Decision date
- February 14, 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 |
|---|---|---|
| K212229 | White Endoseal MTAKIF · Special | 08/13/2021SE |
| K202015 | White ENDOSEAL MTAKIF · Traditional | 03/24/2021SE |
| K201799 | CleaniCalEJK · Traditional | 02/12/2021SE |
| K170175 | Endoseal MtaKIF · Traditional | 02/26/2018SE |
| K133054 | EndosealKIF · Traditional | 05/12/2014SE |
| K133042 | Endocem ZRKIF · Traditional | 05/12/2014SE |
| K112078 | Endocem Mta (Mineral Trioxide Aggregate)KIF · Traditional | 03/19/2012SE |
Questions and answers
When was Endocem MTA Premixed Regular cleared by the FDA?
Endocem MTA Premixed Regular (K213757) received a 510(k) decision of Substantially Equivalent on February 14, 2023, 441 days after the submission was received.
What is the product code of K213757?
The FDA product code is KIF – Resin, Root Canal Filling, a Class II (moderate risk) device regulated under 21 CFR 872.3820.