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510(k) K971063

OPTIMA PLUS E DENTAL CHAIR; A DENTAL CHAIR; EXCEL CHAIR by King Dental Corp. — Product Code KLC

K971063 is an FDA 510(k) premarket notification submitted by King Dental Corp. for the device "OPTIMA PLUS E DENTAL CHAIR; A DENTAL CHAIR; EXCEL CHAIR". The FDA issued a decision of Substantially Equivalent on June 3, 1997. The device falls under product code KLC (Chair, Dental, With Operative Unit), a Class I device regulated under 21 CFR 872.6250. King Dental Corp. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 1997
Date Received
March 24, 1997
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 King Dental Corp.

  • K931162 — KING-HUE, ROYAL CORAL, SUPER-C ARTIFICIAL TEETH (May 27, 1993)

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)
  • 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)
  • K925318 — A-DEC 2181 DUO UNIT (December 9, 1993)

FDA data resources