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510(k) K894060

ESSE QUATTRO/ESSE UNO by Eurodent, Inc. — Product Code KLC

K894060 is an FDA 510(k) premarket notification submitted by Eurodent, Inc. for the device "ESSE QUATTRO/ESSE UNO". The FDA issued a decision of Substantially Equivalent on September 7, 1989. The device falls under product code KLC (Chair, Dental, With Operative Unit), a Class I device regulated under 21 CFR 872.6250. Eurodent, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 1989
Date Received
June 7, 1989
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 Eurodent, Inc.

  • K050571 — ABSOLUTE AMERICA (November 2, 2005)
  • K894058 — ISODENT (December 21, 1989)
  • K894061 — STUDIO UNO (November 21, 1989)
  • K894059 — ISOLIGHT (September 7, 1989)
  • K790078 — BAR & RIDER, SCREWS, TUBES (February 27, 1979)

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