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510(k) K923461

PM2002 PROLINE, PM2002 PROLINE EC by Planmeca USA, Inc. — Product Code KLC

K923461 is an FDA 510(k) premarket notification submitted by Planmeca USA, Inc. for the device "PM2002 PROLINE, PM2002 PROLINE EC". The FDA issued a decision of Substantially Equivalent on December 21, 1992. The device falls under product code KLC (Chair, Dental, With Operative Unit), a Class I device regulated under 21 CFR 872.6250. Planmeca USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 1992
Date Received
July 14, 1992
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 USA, Inc.

  • K111361 — PLANMED NUANCE EXCEL (September 23, 2011)
  • K081699 — PLANMECA SOVEREIGN (August 29, 2008)
  • K923534 — PM2002 PROLINE (January 31, 1994)
  • K923533 — ADMARK (March 4, 1993)
  • K923462 — DELIGHT (December 21, 1992)
  • K904953 — PLANMED SOPHIE (April 18, 1991)
  • K904947 — PM2002 CC, ARISTOCRAT AND ARISTOCRAT DELUXE (January 30, 1991)
  • K904948 — PM2002 CC AND PM2002 EC (January 30, 1991)
  • K864474 — DENTAL RADIOGRAPHIC 90, MODEL PM 2002 CC PANORAMIC (November 26, 1986)
  • K842359 — AUTOMATIC PATIENT CHAIR PM2000 & A (September 19, 1984)

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)
  • K963209 — PROSTYLE COMPACT (October 24, 1996)
  • 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)

FDA data resources