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510(k) K955176

DENTO-SURGE by Ellman Intl., Inc. — Product Code EKZ

K955176 is an FDA 510(k) premarket notification submitted by Ellman Intl., Inc. for the device "DENTO-SURGE". The FDA issued a decision of Substantially Equivalent on April 15, 1996. The device falls under product code EKZ (Unit, Electrosurgical, And Accessories, Dental), a Class II device regulated under 21 CFR 872.4920. Ellman Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 1996
Date Received
November 13, 1995
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 by Ellman Intl., Inc.

  • K013255 — SURGITRON 120 IEC (ALSO KNOWN AS SURGITRON 4.0 DUAL RF (November 7, 2001)
  • K003126 — BIPOLAR TRIGGER-FLEX PROBE (April 11, 2001)
  • K001986 — SURGITRON IEC II (September 27, 2000)
  • K001407 — SURGITRON IEC II (July 24, 2000)
  • K001253 — SURGITRON IEC II (May 26, 2000)
  • K992382 — SURGITRON RADIOLASE (October 14, 1999)
  • K990146 — SURGITRON (March 17, 1999)
  • K980177 — SUGITRON MODEL: IEC (July 7, 1998)
  • K980170 — SURGITRON (June 29, 1998)
  • K972072 — SURGITRON MODEL FFPF-EMC (June 19, 1997)

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