iRoot SP Plus
FDA 510(k) K231259 · Innovative Bioceramix, Inc.
510(k) numberK231259
Submission
- Device name
- iRoot SP Plus
- Applicant
- Innovative Bioceramix, Inc.
Burnaby, CA - Received
- May 1, 2023
- Decision date
- May 31, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| 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 |
|---|---|---|
| K222992 | iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material…KIF · Traditional | 11/22/2022SE |
| K130312 | Iroot FMKIF · Traditional | 09/18/2014SE |
| K102867 | Iroot FSKIF · Special | 12/03/2010SE |
| K092715 | Iroot BP PlusKIF · Special | 09/28/2009SE |
| K082943 | Iroot BP, Model Irbp 4609KIF · Traditional | 01/06/2009SE |
| K080917 | Iroot SPKIF · Traditional | 04/09/2008SE |
| K063422 | BioaggregateKIF · Traditional | 11/21/2006SE |
Questions and answers
When was iRoot SP Plus cleared by the FDA?
iRoot SP Plus (K231259) received a 510(k) decision of Substantially Equivalent on May 31, 2023, 30 days after the submission was received.
What is the product code of K231259?
The FDA product code is KIF – Resin, Root Canal Filling, a Class II (moderate risk) device regulated under 21 CFR 872.3820.