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510(k) K071632

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

K071632 is an FDA 510(k) premarket notification submitted by Coltene/Whaledent, Inc. for the device "PERFECT TISSUE CONTOURING SYSTEM II". The FDA issued a decision of Substantially Equivalent on October 18, 2007. The device falls under product code EKZ (Unit, Electrosurgical, And Accessories, Dental), a Class II device regulated under 21 CFR 872.4920. Coltene/Whaledent, Inc. has at least 10 other 510(k) clearances on record.

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

Other clearances by Coltene/Whaledent, Inc.

  • K191385 — BRILLIANT COMPONEER (October 29, 2019)
  • K190597 — BRILLIANT EverGlow Flow (June 21, 2019)
  • K181500 — BRILLIANT Crios (August 15, 2018)
  • K160800 — DuoCem (November 16, 2016)
  • K152927 — BRILLIANT EVERGLOW (April 28, 2016)
  • K152243 — One Coat 7 Universal (December 9, 2015)
  • K150218 — Fill-Up! (June 23, 2015)
  • K130137 — BIOSONIC SUVI PIEZEOELECTRIC SCALER AND POLISHER (August 23, 2013)
  • K121621 — SOLOCEM (January 8, 2013)
  • K112168 — COMPONEER (November 21, 2011)

Other clearances for product code EKZ

  • K213477 — Root ZX3 (August 3, 2022)
  • 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)
  • K981390 — ODONTOSURGE 2 (June 11, 1998)

FDA data resources