KIFClass II
Resin, Root Canal Filling
21 CFR 872.3820 / Dental
KIF is the FDA product code for Resin, Root Canal Filling, a class II device type, regulated under 21 CFR 872.3820. As of , FDA records hold 145 510(k) clearances under this code, the most recent dated , and 2 recalls.
Classification record
- Product code
- KIF
- Device name
- Resin, Root Canal Filling
- Regulation
- 21 CFR 872.3820
- Device class
- Class II
- Review panel
- Dental
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 147
- Ingested recalls
- 2
Clearances, product code KIF
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1980 | 1 |
| 1981 | 1 |
| 1982 | 1 |
| 1983 | 1 |
| 1985 | 2 |
| 1989 | 1 |
| 1990 | 3 |
| 1992 | 1 |
| 1993 | 1 |
| 1994 | 2 |
| 1995 | 2 |
| 1996 | 4 |
| 1997 | 5 |
| 1998 | 4 |
| 1999 | 1 |
| 2000 | 1 |
| 2001 | 3 |
| 2002 | 1 |
| 2003 | 5 |
| 2004 | 3 |
| 2006 | 3 |
| 2007 | 2 |
| 2008 | 4 |
| 2009 | 5 |
| 2010 | 5 |
| 2012 | 5 |
| 2013 | 2 |
| 2014 | 10 |
| 2015 | 1 |
| 2016 | 5 |
| 2017 | 3 |
| 2018 | 5 |
| 2019 | 7 |
| 2020 | 3 |
| 2021 | 12 |
| 2022 | 3 |
| 2023 | 7 |
| 2024 | 8 |
| 2025 | 7 |
| 2026 | 6 |
Applicants with the most clearances
Product code KIF| Applicant | Clearances |
|---|---|
| Meta Biomed Co., Ltd. | 9 |
| Innovative BioCeramix, Inc | 8 |
| Maruchi | 7 |
| Sybron Dental Specialties, Inc. | 7 |
| Diadent Group International | 6 |
| Pulpdent Corporation | 6 |
| Angelus Industria de Produtos Odontologicos S/A | 5 |
| Dentsply Intl. | 5 |
| Septodont | 5 |
| Ultradent Products Inc. | 5 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.