EBCClass II
Sealant, Pit And Fissure, And Conditioner
21 CFR 872.3765 / Dental
EBC is the FDA product code for Sealant, Pit And Fissure, And Conditioner, a class II device type, regulated under 21 CFR 872.3765. As of , FDA records hold 131 510(k) clearances under this code, the most recent dated , and 3 recalls.
Classification record
- Product code
- EBC
- Device name
- Sealant, Pit And Fissure, And Conditioner
- Regulation
- 21 CFR 872.3765
- 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
- 131
- Ingested recalls
- 3
Clearances, product code EBC
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 2 |
| 1977 | 2 |
| 1979 | 3 |
| 1980 | 4 |
| 1981 | 5 |
| 1983 | 1 |
| 1984 | 4 |
| 1985 | 4 |
| 1986 | 5 |
| 1987 | 2 |
| 1988 | 4 |
| 1989 | 3 |
| 1990 | 5 |
| 1991 | 5 |
| 1992 | 6 |
| 1993 | 7 |
| 1994 | 1 |
| 1995 | 4 |
| 1996 | 4 |
| 1997 | 2 |
| 1998 | 1 |
| 1999 | 9 |
| 2000 | 1 |
| 2001 | 6 |
| 2002 | 3 |
| 2003 | 1 |
| 2004 | 2 |
| 2005 | 4 |
| 2006 | 5 |
| 2007 | 1 |
| 2008 | 1 |
| 2009 | 2 |
| 2010 | 5 |
| 2011 | 3 |
| 2012 | 1 |
| 2013 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 2 |
| 2018 | 1 |
| 2019 | 2 |
| 2023 | 2 |
| 2025 | 1 |
| 2026 | 1 |
Applicants with the most clearances
Product code EBC| Applicant | Clearances |
|---|---|
| Dentsply Intl. | 11 |
| Pulpdent Corporation | 10 |
| Ultradent Products Inc. | 7 |
| Confi-Dental Products Co. | 4 |
| Foremost Dental Mfg., Inc. | 3 |
| Harry J. Bosworth Co. | 3 |
| Johnson & Johnson Professionals, Inc. | 3 |
| Voco GmbH | 3 |
| Wallace A. Erickson & Co. | 3 |
| 3M Company | 2 |
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.