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510(k) K071632

PERFECT TISSUE CONTOURING SYSTEM II by Coltene/Whaledent, Inc. — Product Code EKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2007
Date Received
June 14, 2007
Clearance Type
Abbreviated
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

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Other clearances for product code EKZ

  • K213477 — Root ZX3 (August 3, 2022)
  • K063468 — THE FUGO BLADE FOR DENTISTRY (April 18, 2007)
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  • 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)