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510(k) K151987

DCI Edge Dental Chair with Operative Unit by Dci — Product Code KLC

K151987 is an FDA 510(k) premarket notification submitted by Dci for the device "DCI Edge Dental Chair with Operative Unit". The FDA issued a decision of Substantially Equivalent on June 1, 2016. The device falls under product code KLC (Chair, Dental, With Operative Unit), a Class I device regulated under 21 CFR 872.6250.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 2016
Date Received
July 17, 2015
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 for product code KLC

  • K233921 — Luvis Chair (LC700C) (September 6, 2024)
  • 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)
  • K925119 — A-DEC 1040 CHAIR (January 31, 1994)
  • K923534 — PM2002 PROLINE (January 31, 1994)
  • K925318 — A-DEC 2181 DUO UNIT (December 9, 1993)

FDA data resources