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510(k) K050735

MC6A by Macan Engineering Co. — Product Code EKZ

K050735 is an FDA 510(k) premarket notification submitted by Macan Engineering Co. for the device "MC6A". The FDA issued a decision of Substantially Equivalent on May 23, 2005. The device falls under product code EKZ (Unit, Electrosurgical, And Accessories, Dental), a Class II device regulated under 21 CFR 872.4920. Macan Engineering Co. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2005
Date Received
March 21, 2005
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 Macan Engineering Co.

  • K052622 — MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT (December 9, 2005)

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)
  • 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)
  • K981390 — ODONTOSURGE 2 (June 11, 1998)

FDA data resources