EKM — Gutta-Percha Class I
FDA Device Classification
Classification Details
- Product Code
- EKM
- Device Class
- Class I
- Regulation Number
- 872.3850
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K073369 | hu-friedy mfg. co | EI DOWNPAK BARRIER SLEEVES | February 27, 2008 |
| K070246 | endo twinn | DOWN PAK | February 16, 2007 |
| K051573 | howard martin, p.a | TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE) | June 26, 2006 |
| K042870 | endo twinn | ENDO TWINN | January 11, 2005 |
| K023819 | pentron clinical technologies | FIBERFILL SGP | March 26, 2003 |
| K971641 | howard martin, p.a | ANTIBACTERIAL GUTTA PERCHA | July 21, 1997 |
| K970134 | tulsa dental products | THERMAPREP PLUS OVEN | March 21, 1997 |
| K931742 | union broach, div. moyco industries | INJECT-R FILL | May 27, 1993 |
| K924825 | unicep | MICRODOSE RC-EZ | March 5, 1993 |
| K915243 | analytic technology | TOUCH 'N HEAT MODEL 5002, MODIFICATION | January 21, 1992 |
| K910224 | tulsa dental products | THERMAPREP | March 29, 1991 |
| K900986 | tulsa dental products | THERMAFIL ENDODONTIC OBTURATOR | November 13, 1990 |
| K896663 | pulpdent | ENDO-PREP | February 14, 1990 |
| K881139 | tulsa dental products | THERMAFIL ENDODONTIC OBTURATOR | April 7, 1988 |
| K863411 | endodent | GUTTA PERCHA | October 30, 1986 |
| K863638 | endodent | GUTTA PERCHA POINTS | October 30, 1986 |
| K862129 | endo technic | SET CANAL SEALER PASTE | July 22, 1986 |
| K850863 | hygenic | ULTRAFIL-LT (GUTTA PERCHA) | April 16, 1985 |
| K832654 | unitek | HEATED GUTTA PERCHA DELIVERY SYSTEM | September 26, 1983 |
| K830114 | north pacific dental | GUTTA PERCHA POINTS | March 1, 1983 |