EKR — Plugger, Root Canal, Endodontic Class I
FDA product code EKR covers "Plugger, Root Canal, Endodontic", a Class I medical device regulated under 21 CFR 872.4565. Submissions are reviewed by the Dental panel. At least 6 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- EKR
- Device Class
- Class I
- Regulation Number
- 872.4565
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K060347 | b and l biotech co | B&L L-BETA, MODEL WL-B1 | June 5, 2006 |
| K042828 | young o/s | OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700 | December 1, 2004 |
| K031664 | sybron endo/analytic | ELEMENTS OBTURATION UNIT | April 28, 2004 |
| K860569 | dentsply intl | ENDODONTIC ROOT CANAL PLUGGER | March 26, 1986 |
| K831748 | union branch | ENDODONTIC ROOT CANAL PLUGGER FINGER- | July 12, 1983 |
| K791019 | techdent | MCSPADDEN CONDENSOR | August 3, 1979 |