Product code EKZ— Dental
ARTHROCARE DENTAL ELECTROSURGERY SYSTEM
- Classification name
- Unit, Electrosurgical, And Accessories, Dental
- Device class
- Class 2
- Regulation
- 21 CFR 872.4920
- Advisory panel
- Dental
- Total cleared
- 19
- First cleared
- Most recent
Market context for product code EKZ
FDA has cleared devices under product code EKZ between 1983 and 2022, filed by 18 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2022
- 2007
- 2005
- 2003
- 2002
- 2000
- 1998
- 1996
- 1995
- 1994
- 1992
- 1985
- 1983
Top applicants under product code EKZ
Recent clearances under product code EKZ
- K213477 — Root ZX3
- K071632 — PERFECT TISSUE CONTOURING SYSTEM II
- K063468 — THE FUGO BLADE FOR DENTISTRY
- K052622 — MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT
- K050735 — MC6A
- K023672 — X O ODONTOSURGE 4
- K020080 — BONART ART-E1 ELECTROSURGERY UNIT
- K001560 — ODONTOSURGE 3
- K000768 — WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR
- K982229 — BI-DENT
- K981390 — ODONTOSURGE 2
- K962445 — ARTHROCARE DENTAL ELECTROSURGERY SYSTEM
- K955176 — DENTO-SURGE
- K950239 — SENSIMATIC 500SE
- K925116 — ELECTROSURGICAL ELECTRODE
- K921604 — TOUCH N' HEAT, MODIFICATION
- K852522 — SATALEC SERVOTOME
- K850666 — STROBEX ULTRON ELECTROSURGE-DENTAL UNIT
- K830441 — DIFF 4 SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.