Hydron Root Canal Filling System
FDA 510(k) K771921 · National Patent Development Corp.
510(k) numberK771921
Submission
- Device name
- Hydron Root Canal Filling System
- Applicant
- National Patent Development Corp.
Mchenry, IL, US - Received
- October 12, 1977
- Decision date
- November 15, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code KIF
| 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 |
|---|---|---|
| K843974 | Variable Temperature Cautery DeviceGEI · Traditional | 02/26/1985SE |
| K832699 | Hydron Wound Dressing Fast Seat KitFRO · Traditional | 04/27/1984SE |
| K822793 | Pio Root Canal IndicatorEIL · Traditional | 10/22/1982SE |
| K820028 | Zeon Composite Resin Light Cure SysEBF · Traditional | 03/11/1982SE |
| K820006 | Zeon Composite Resin SystemEBF · Traditional | 01/22/1982SE |
| K811446 | Hydron Wound Dressing KitKMF · Traditional | 06/12/1981SE |
| K801484 | Root Canal Filling Applicator NeedlesEIC · Traditional | 07/21/1980SE |
| K801483 | Mark IV SyringeEIC · Traditional | 07/21/1980SE |
| K801482 | Hydron Root Canal Filling MaterialKIF · Traditional | 07/21/1980SE |
| K792136 | Hypo-Allergenic Plastic TapeFPX · Traditional | 01/16/1980SE |
Questions and answers
When was Hydron Root Canal Filling System cleared by the FDA?
Hydron Root Canal Filling System (K771921) received a 510(k) decision of Substantially Equivalent on November 15, 1977, 34 days after the submission was received.
What is the product code of K771921?
The FDA product code is KIF – Resin, Root Canal Filling, a Class II (moderate risk) device regulated under 21 CFR 872.3820.