Simpliseal
FDA 510(k) K093208 · Discus Dental, LLC
510(k) numberK093208
Submission
- Device name
- Simpliseal
- Applicant
- Discus Dental, LLC
Culver City, CA, US - Received
- October 13, 2009
- Decision date
- February 12, 2010
- 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 |
|---|---|---|
| K102639 | SL3GEX · Special | 12/01/2010SE |
| K101612 | Zen Cordless Prophy SystemEKX · Traditional | 06/30/2010SE |
| K101215 | NuanceEBF · Traditional | 05/12/2010SE |
| K092417 | Insight Ultrasonic InsertsELC · Traditional | 12/11/2009SE |
| K073518 | Flashlite Rebel*EBZ · Traditional | 12/20/2007SE |
| K062176 | Relief Acp Oral Care GelLBH · Traditional | 01/10/2007SE |
| K052090 | Splash! Impression Material DeviceELW · Traditional | 08/05/2005SE |
| K051776 | Protege Ultrasonic InsertELC · Traditional | 07/13/2005SE |
| K033785 | Proactive Care Prophylaxis Paste with FluorideEJR · Traditional | 06/18/2004SE |
| K040053 | Precision VPS Impression MaterialELW · Traditional | 03/25/2004SE |
Questions and answers
When was Simpliseal cleared by the FDA?
Simpliseal (K093208) received a 510(k) decision of Substantially Equivalent on February 12, 2010, 122 days after the submission was received.
What is the product code of K093208?
The FDA product code is KIF – Resin, Root Canal Filling, a Class II (moderate risk) device regulated under 21 CFR 872.3820.