KJJUnclassified
Cleanser, Root Canal
Unknown
KJJ is the FDA product code for Cleanser, Root Canal. As of , FDA records hold 41 510(k) clearances under this code, the most recent dated , and 7 recalls.
Classification record
- Product code
- KJJ
- Device name
- Cleanser, Root Canal
- Device class
- Unclassified
- Review panel
- Unknown
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 41
- Ingested recalls
- 7
Clearances, product code KJJ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1978 | 1 |
| 1980 | 1 |
| 1983 | 1 |
| 1993 | 1 |
| 1994 | 1 |
| 1995 | 1 |
| 1996 | 1 |
| 1999 | 2 |
| 2001 | 1 |
| 2003 | 3 |
| 2004 | 1 |
| 2005 | 1 |
| 2006 | 3 |
| 2007 | 3 |
| 2009 | 1 |
| 2011 | 2 |
| 2013 | 2 |
| 2014 | 2 |
| 2015 | 2 |
| 2016 | 2 |
| 2017 | 1 |
| 2018 | 1 |
| 2020 | 3 |
| 2021 | 2 |
| 2024 | 1 |
| 2025 | 1 |
Applicants with the most clearances
Product code KJJ| Applicant | Clearances |
|---|---|
| Ultradent Products Inc. | 5 |
| Dentsply Intl. | 4 |
| Essential Dental Systems, Inc. | 3 |
| Inter-Med, Inc. | 3 |
| Pac-Dent International, Inc. | 3 |
| Epien Medical, Inc. | 2 |
| Straumann USA, LLC | 2 |
| Inter-Med/Vista Dental Products | 2 |
| Super Glide, Inc. | 2 |
| A and V Ent. | 1 |
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.
