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510(k) K940950

KAVO SYSTEMATICA 1060 by Kavo America — Product Code KLC

K940950 is an FDA 510(k) premarket notification submitted by Kavo America for the device "KAVO SYSTEMATICA 1060". The FDA issued a decision of Substantially Equivalent on December 29, 1994. The device falls under product code KLC (Chair, Dental, With Operative Unit), a Class I device regulated under 21 CFR 872.6250. Kavo America has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1994
Date Received
February 28, 1994
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 Kavo America

  • K073074 — KEY LASER III 1243 US WITH DETECT (July 10, 2008)
  • K072262 — GENTLERAY 980 DIODE LASER SYSTEM (October 26, 2007)
  • K063624 — KAVO EVEREST C-TEMP (February 8, 2007)
  • K051909 — DIAGNODENT (October 21, 2005)
  • K030146 — KAVO KEY LASER 1242 AND KAVO KEY LASER 1243+ (August 3, 2005)
  • K050019 — IN EXAM INTRAORAL DENTAL X-RAY SYSTEM (January 31, 2005)
  • K032081 — KAVO EVEREST ZS-BLANK MODELS, 42, 20, AND 60 (July 24, 2003)
  • K031868 — PROPHYPEARLS (July 9, 2003)
  • K030607 — KAVO EVEREST G-BLANK, KAVO EVEREST G-CERAM, COATING CERAMIC LF-3-PFM, GLAZE AND (May 2, 2003)
  • K024214 — KAVO EVEREST TITANBLANK (March 12, 2003)

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)
  • 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