KLEClass II
Agent, Tooth Bonding, Resin
21 CFR 872.3200 / Dental
KLE is the FDA product code for Agent, Tooth Bonding, Resin, a class II device type, regulated under 21 CFR 872.3200. As of , FDA records hold 419 510(k) clearances under this code, the most recent dated , and 20 recalls.
Classification record
- Product code
- KLE
- Device name
- Agent, Tooth Bonding, Resin
- Regulation
- 21 CFR 872.3200
- 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
- 420
- Ingested recalls
- 20
Clearances, product code KLE
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 2 |
| 1977 | 3 |
| 1979 | 2 |
| 1980 | 6 |
| 1981 | 4 |
| 1982 | 2 |
| 1983 | 3 |
| 1984 | 6 |
| 1985 | 2 |
| 1986 | 4 |
| 1987 | 3 |
| 1988 | 2 |
| 1989 | 10 |
| 1990 | 12 |
| 1991 | 9 |
| 1992 | 10 |
| 1993 | 11 |
| 1994 | 17 |
| 1995 | 21 |
| 1996 | 16 |
| 1997 | 18 |
| 1998 | 15 |
| 1999 | 14 |
| 2000 | 10 |
| 2001 | 14 |
| 2002 | 17 |
| 2003 | 10 |
| 2004 | 14 |
| 2005 | 15 |
| 2006 | 13 |
| 2007 | 14 |
| 2008 | 3 |
| 2009 | 7 |
| 2010 | 8 |
| 2011 | 10 |
| 2012 | 5 |
| 2013 | 11 |
| 2014 | 6 |
| 2015 | 10 |
| 2016 | 3 |
| 2017 | 4 |
| 2018 | 8 |
| 2019 | 6 |
| 2020 | 6 |
| 2021 | 4 |
| 2022 | 8 |
| 2023 | 6 |
| 2024 | 7 |
| 2025 | 3 |
| 2026 | 6 |
Applicants with the most clearances
Product code KLE| Applicant | Clearances |
|---|---|
| Dentsply Intl. | 20 |
| Kulzer GmbH | 20 |
| Ultradent Products Inc. | 19 |
| Parkell, Inc. | 16 |
| Kuraray Medical, Inc. | 14 |
| Shofu Dental Corp. | 13 |
| Sybron Dental Specialties, Inc. | 12 |
| GC America Inc. | 11 |
| Pulpdent Corporation | 11 |
| Ivoclar Vivadent, Inc. | 10 |
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.