EKZ — Unit, Electrosurgical, And Accessories, Dental Class II
FDA product code EKZ covers "Unit, Electrosurgical, And Accessories, Dental", a Class II medical device regulated under 21 CFR 872.4920. Submissions are reviewed by the Dental panel. At least 19 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- EKZ
- Device Class
- Class II
- Regulation Number
- 872.4920
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K213477 | j. morita usa | Root ZX3 | August 3, 2022 |
| K071632 | coltene/whaledent | PERFECT TISSUE CONTOURING SYSTEM II | October 18, 2007 |
| K063468 | medisurg | THE FUGO BLADE FOR DENTISTRY | April 18, 2007 |
| K052622 | macan engineering | MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT | December 9, 2005 |
| K050735 | macan engineering | MC6A | May 23, 2005 |
| K023672 | xo care | X O ODONTOSURGE 4 | April 29, 2003 |
| K020080 | diagnostic data | BONART ART-E1 ELECTROSURGERY UNIT | February 19, 2002 |
| K001560 | odonto-wave | ODONTOSURGE 3 | August 24, 2000 |
| K000768 | wallach surgical devices | WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR | April 11, 2000 |
| K982229 | valley forge scientific | BI-DENT | August 13, 1998 |
| K981390 | periogiene | ODONTOSURGE 2 | June 11, 1998 |
| K962445 | arthrocare | ARTHROCARE DENTAL ELECTROSURGERY SYSTEM | July 30, 1996 |
| K955176 | ellman intl | DENTO-SURGE | April 15, 1996 |
| K950239 | parkell | SENSIMATIC 500SE | June 6, 1995 |
| K925116 | premier | ELECTROSURGICAL ELECTRODE | March 1, 1994 |
| K921604 | analytic technology | TOUCH N' HEAT, MODIFICATION | August 24, 1992 |
| K852522 | spelna | SATALEC SERVOTOME | December 27, 1985 |
| K850666 | ipco | STROBEX ULTRON ELECTROSURGE-DENTAL UNIT | May 29, 1985 |
| K830441 | coulter electronics | DIFF 4 SYSTEM | May 16, 1983 |