Sealer Solvent
FDA 510(k) K241354 · Inter-Med, Inc.
510(k) numberK241354
Submission
- Device name
- Sealer Solvent
- Applicant
- Inter-Med, Inc.
Racine, WI, US - Received
- May 13, 2024
- Decision date
- August 27, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KJJ – Cleanser, Root Canal
- Device class
- Unclassified
Other 510(k)s with product code KJJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250279 | RC-SwiftPrepKJJ · Traditional | Belport Company, Inc., Gingi-Pak | 07/02/2025SE |
| K201785 | EPIEN Dental CleanserKJJ · Traditional | Epien Medical, Inc. | 09/09/2021SE |
| K211813 | TritonKJJ · Special | Inter-Med / Vista Dental | 08/18/2021SE |
| K193357 | V-MixKJJ · Traditional | Inter-Med/Vista Dental Products | 10/23/2020SE |
| K193409 | Vista Rinse, Vista Rinse PlusKJJ · Traditional | Inter-Med/Vista Dental Products | 09/09/2020SE |
| K200330 | RC-Prime Root Canal Preparation CreamKJJ · Traditional | Pac-Dent, Inc. | 07/06/2020SE |
| K173163 | ChlorCid, ChlorCid V, ChlorCid SurfKJJ · Traditional | Ultradent Products, Inc. | 02/09/2018SE |
| K162311 | Straumann PrefGelKJJ · Traditional | Institut Straumann AG | 03/07/2017SE |
| K160577 | PacEndo ChlorhexidineKJJ · Traditional | Pac-Dent International, Inc. | 07/25/2016SE |
| K153528 | PacEndo EDTAKJJ · Traditional | Pac-Dent International, Inc. | 02/01/2016SE |
More from Pac-Dent International, Inc.
| 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 |
| K221811 | Vista BC SealerKIF · Traditional | 11/21/2022SE |
| 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 Sealer Solvent cleared by the FDA?
Sealer Solvent (K241354) received a 510(k) decision of Substantially Equivalent on August 27, 2024, 106 days after the submission was received.
What is the product code of K241354?
The FDA product code is KJJ – Cleanser, Root Canal, a Unclassified device.