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510(k) K981390

ODONTOSURGE 2 by Periogiene — Product Code EKZ

K981390 is an FDA 510(k) premarket notification submitted by Periogiene for the device "ODONTOSURGE 2". The FDA issued a decision of Substantially Equivalent on June 11, 1998. The device falls under product code EKZ (Unit, Electrosurgical, And Accessories, Dental), a Class II device regulated under 21 CFR 872.4920.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 1998
Date Received
April 16, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Electrosurgical, And Accessories, Dental
Device Class
Class II
Regulation Number
872.4920
Review Panel
DE
Submission Type

Other clearances for product code EKZ

  • K213477 — Root ZX3 (August 3, 2022)
  • K071632 — PERFECT TISSUE CONTOURING SYSTEM II (October 18, 2007)
  • K063468 — THE FUGO BLADE FOR DENTISTRY (April 18, 2007)
  • K052622 — MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT (December 9, 2005)
  • K050735 — MC6A (May 23, 2005)
  • K023672 — X O ODONTOSURGE 4 (April 29, 2003)
  • K020080 — BONART ART-E1 ELECTROSURGERY UNIT (February 19, 2002)
  • K001560 — ODONTOSURGE 3 (August 24, 2000)
  • K000768 — WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (April 11, 2000)
  • K982229 — BI-DENT (August 13, 1998)

FDA data resources