Diapaste
FDA 510(k) K190091 · DiaDent Group International
510(k) numberK190091
Submission
- Device name
- Diapaste
- Applicant
- DiaDent Group International
Cheongju-Si, KR - Received
- January 18, 2019
- Decision date
- March 27, 2020
- 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 |
|---|---|---|
| K261166 | Dia-CemEMA · Traditional | 07/09/2026SE |
| K261093 | DiafilEBF · Traditional | 06/02/2026SE |
| K261071 | DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW…EBF · Traditional | 05/19/2026SE |
| 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 |
| K200174 | Dia-Root Bio MtaKIF · Traditional | 09/18/2020SE |
Questions and answers
When was Diapaste cleared by the FDA?
Diapaste (K190091) received a 510(k) decision of Substantially Equivalent on March 27, 2020, 434 days after the submission was received.
What is the product code of K190091?
The FDA product code is KIF – Resin, Root Canal Filling, a Class II (moderate risk) device regulated under 21 CFR 872.3820.