Vista BC Sealer
FDA 510(k) K221811 · Inter-Med, Inc.
510(k) numberK221811
Submission
- Device name
- Vista BC Sealer
- Applicant
- Inter-Med, Inc.
Racine, WI, US - Received
- June 22, 2022
- Decision date
- November 21, 2022
- 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 |
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| 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 |
|---|---|---|
| K253337 | REGEN Bioactive CementEMA · Traditional | 04/15/2026SE |
| K241489 | ReminGelLBH · Traditional | 01/08/2025SE |
| K241457 | Vista BC PuttyKIF · Traditional | 08/28/2024SE |
| K241354 | Sealer SolventKJJ · Traditional | 08/27/2024SE |
| K211721 | PS SystemNYL · Traditional | 12/02/2021SE |
| K112250 | Chx=Chx PlusKJJ · Traditional | 10/28/2011SE |
| K082470 | Sodium Hypochlorite 3 & 6% Solution and 6% with Wetting Agents to Lower Surface Tension…KJJ · Traditional | 04/03/2009SE |
| K871291 | Am Cath Eswl StentFAD · Traditional | 04/30/1987SE |
| K864669 | Am Cath Eswl StentFAD · Traditional | 01/05/1987SE |
| K851922 | Ureteral Stone DislodgerFFL · Traditional | 08/02/1985SE |
Questions and answers
When was Vista BC Sealer cleared by the FDA?
Vista BC Sealer (K221811) received a 510(k) decision of Substantially Equivalent on November 21, 2022, 152 days after the submission was received.
What is the product code of K221811?
The FDA product code is KIF – Resin, Root Canal Filling, a Class II (moderate risk) device regulated under 21 CFR 872.3820.