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510(k) K843233

ANATOM SYSTEM by Lic-Orthion — Product Code KLC

K843233 is an FDA 510(k) premarket notification submitted by Lic-Orthion for the device "ANATOM SYSTEM". The FDA issued a decision of Substantially Equivalent on October 25, 1984. The device falls under product code KLC (Chair, Dental, With Operative Unit), a Class I device regulated under 21 CFR 872.6250. Lic-Orthion has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 1984
Date Received
August 17, 1984
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 Lic-Orthion

  • K891649 — PATIENT EXAMINATION GLOVES (LATEX) (April 4, 1989)
  • K862022 — LIC-ORTHION MULTI-THERAPY TREATMENT TABLE (June 19, 1986)
  • K854730 — DAISY (ABSORBENT INCONTINENCE SHIELD) (February 6, 1986)
  • K854729 — ADAM (ABSORBENT INCONTINENCE SHIELD) (February 6, 1986)
  • K851470 — BIBAG, BIBAND & BIFIX - SINGLE USE URINE COLLECTOR (June 12, 1985)
  • K851471 — TRIBAG, TRIBAND & TRIFIX-REUSEABLE URINE COLLECTOR (June 12, 1985)
  • K843234 — CITOMAT AUTOCLAVES (October 25, 1984)
  • K830853 — LAVATORY SEAT HEIGHTENER (June 8, 1983)
  • K830848 — RESI-WALKER (April 5, 1983)
  • K830855 — SESAM TREATMENT TABLE (April 5, 1983)

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