DYHClass II
Adhesive, Bracket And Tooth Conditioner, Resin
21 CFR 872.3750 / Dental
DYH is the FDA product code for Adhesive, Bracket And Tooth Conditioner, Resin, a class II device type, regulated under 21 CFR 872.3750. As of , FDA records hold 194 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- DYH
- Device name
- Adhesive, Bracket And Tooth Conditioner, Resin
- Regulation
- 21 CFR 872.3750
- 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
- 194
- Ingested recalls
- 1
Clearances, product code DYH
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 2 |
| 1977 | 2 |
| 1978 | 3 |
| 1979 | 3 |
| 1980 | 1 |
| 1981 | 6 |
| 1982 | 1 |
| 1983 | 7 |
| 1984 | 2 |
| 1985 | 4 |
| 1986 | 5 |
| 1987 | 2 |
| 1988 | 13 |
| 1989 | 14 |
| 1991 | 4 |
| 1992 | 10 |
| 1993 | 2 |
| 1994 | 6 |
| 1995 | 20 |
| 1996 | 3 |
| 1997 | 1 |
| 1998 | 1 |
| 1999 | 5 |
| 2000 | 4 |
| 2001 | 4 |
| 2002 | 10 |
| 2003 | 9 |
| 2004 | 5 |
| 2005 | 1 |
| 2006 | 2 |
| 2007 | 3 |
| 2008 | 6 |
| 2009 | 3 |
| 2010 | 4 |
| 2011 | 2 |
| 2012 | 3 |
| 2013 | 1 |
| 2015 | 5 |
| 2016 | 2 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 3 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 2 |
| 2024 | 1 |
| 2025 | 1 |
| 2026 | 2 |
Applicants with the most clearances
Product code DYH| Applicant | Clearances |
|---|---|
| Reliance Orthodontic Products, Inc. | 23 |
| Sybron Dental Specialties, Inc. | 12 |
| Pulpdent Corporation | 9 |
| American Orthodontics | 8 |
| Dentsply Intl. | 8 |
| Ormco Corp. | 8 |
| Scientific Pharmaceuticals, Inc. | 7 |
| 3M UNITEK Corporation | 6 |
| American Dental Products, Inc. | 6 |
| Confi-Dental Products Co. | 6 |
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.
