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510(k) K963209

PROSTYLE COMPACT by Planmeca Oy — Product Code KLC

K963209 is an FDA 510(k) premarket notification submitted by Planmeca Oy for the device "PROSTYLE COMPACT". The FDA issued a decision of Substantially Equivalent on October 24, 1996. The device falls under product code KLC (Chair, Dental, With Operative Unit), a Class I device regulated under 21 CFR 872.6250. Planmeca Oy has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1996
Date Received
August 16, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chair, Dental, With Operative Unit
Device Class
Class I
Regulation Number
872.6250
Review Panel
DE
Submission Type

Other clearances by Planmeca Oy

  • K230985 — Planmeca Viso (December 28, 2023)
  • K200572 — Planmeca Romexis (December 2, 2020)
  • K181576 — Planmeca Viso (September 13, 2018)
  • K171385 — Planmeca Romexis (November 14, 2017)
  • K160506 — Planmeca ProMax 3D Max, Planmeca Maximity (May 20, 2016)
  • K140713 — PLANMECA ROMEXIS (June 16, 2014)
  • K103689 — PLANMECA PROMAX 3D MID (March 17, 2011)
  • K093590 — PLANMECA PROMAX 3D MAX (May 12, 2010)
  • K091197 — PLANMECA PROSENSOR (July 29, 2009)
  • K072244 — PLANMECA PROONE (September 21, 2007)

Other clearances for product code KLC

  • K233921 — Luvis Chair (LC700C) (September 6, 2024)
  • K151987 — DCI Edge Dental Chair with Operative Unit (June 1, 2016)
  • K071353 — FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48C (December 14, 2007)
  • K971063 — OPTIMA PLUS E DENTAL CHAIR; A DENTAL CHAIR; EXCEL CHAIR (June 3, 1997)
  • K942870 — ULTIMA 2 DENTAL CHAIR (February 27, 1995)
  • K940950 — KAVO SYSTEMATICA 1060 (December 29, 1994)
  • K925567 — E 4000 DENTAL OPERATING CHAIR (March 10, 1994)
  • K923534 — PM2002 PROLINE (January 31, 1994)
  • K925119 — A-DEC 1040 CHAIR (January 31, 1994)
  • K925318 — A-DEC 2181 DUO UNIT (December 9, 1993)

FDA data resources