Dia-Root Bio Mta
FDA 510(k) K200174 · DiaDent Group International
510(k) numberK200174
Submission
- Device name
- Dia-Root Bio Mta
- Applicant
- DiaDent Group International
Cheongju-Si, KR - Received
- January 23, 2020
- Decision date
- September 18, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| 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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| K254112 | Dia-X Sil BiteELW · Traditional | 03/19/2026SE |
| K231552 | Dia-CemEMA · Traditional | 07/28/2023SE |
| K220804 | Dia-X Bond UniversalKLE · Special | 06/15/2022SE |
| K213401 | DIAPLUS UniversalKLE · Traditional | 01/31/2022SE |
| K210421 | Diafil & Diafil CapsuleEBF · Special | 06/28/2021SE |
| K210333 | DiaPasteKIF · Special | 03/25/2021SE |
| K200809 | D-Lux+EBZ · Traditional | 08/07/2020SE |
Questions and answers
When was Dia-Root Bio Mta cleared by the FDA?
Dia-Root Bio Mta (K200174) received a 510(k) decision of Substantially Equivalent on September 18, 2020, 239 days after the submission was received.
What is the product code of K200174?
The FDA product code is KIF – Resin, Root Canal Filling, a Class II (moderate risk) device regulated under 21 CFR 872.3820.