Endosolv
FDA 510(k) K172839 · Septodont
510(k) numberK172839
Submission
- Device name
- Endosolv
- Applicant
- Septodont
Louisville, CO, US - Received
- September 19, 2017
- Decision date
- February 13, 2018
- 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 |
More from Voco GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K212283 | BioRoot Flow 0.5g, BioRoot Flow 2gKIF · Traditional | 09/16/2021SE |
| K211799 | Biodentine XP 500, Biodentine XP 200KIF · Traditional | 08/10/2021SE |
| K140132 | BiodentineKIF · Traditional | 06/27/2014SE |
| K093711 | RacegelMVL · Traditional | 02/17/2010SE |
| K092251 | BiodentineKIF · Traditional | 10/30/2009SE |
| K063634 | RTR SyringeLYC · Abbreviated | 05/11/2007SE |
| K051010 | Securalloy, Septalloy NG 50 and Septalloy NG 70EJJ · Special | 05/02/2005SE |
| K032708 | Plastalgin and Plastalgin OrthoELW · Traditional | 11/20/2003SE |
| K780003 | Endosolv EKJJ · Traditional | 01/20/1978SE |
| K771114 | NeutrocimEMA · Traditional | 01/04/1978SE |
Questions and answers
When was Endosolv cleared by the FDA?
Endosolv (K172839) received a 510(k) decision of Substantially Equivalent on February 13, 2018, 147 days after the submission was received.
What is the product code of K172839?
The FDA product code is KIF – Resin, Root Canal Filling, a Class II (moderate risk) device regulated under 21 CFR 872.3820.