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510(k) K920017

IMPROVED DENTAL OPERATING LIGHT by Den-Tal-Ez Mfg Co., Inc. — Product Code KLC

K920017 is an FDA 510(k) premarket notification submitted by Den-Tal-Ez Mfg Co., Inc. for the device "IMPROVED DENTAL OPERATING LIGHT". The FDA issued a decision of Substantially Equivalent on March 2, 1992. The device falls under product code KLC (Chair, Dental, With Operative Unit), a Class I device regulated under 21 CFR 872.6250. Den-Tal-Ez Mfg Co., Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 1992
Date Received
January 2, 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 Den-Tal-Ez Mfg Co., Inc.

  • K925629 — ACCESSORY TO IMPROVED DENTAL OPERATING LIGHT (November 23, 1993)
  • K932824 — EVACUATOR, ORAL CAVITY (September 28, 1993)
  • K931204 — AS3000 OPERATIVE DENTAL UNIT (DELIVERY SYSTEM) (July 8, 1993)
  • K920016 — IMPROVED DENTAL CHAIR (March 2, 1992)
  • K874294 — AUTOCHUCK ATTACHMENT (December 29, 1987)
  • K780469 — PANORAMIC X-RAY, DENTAL (April 10, 1978)

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