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510(k) K071353

FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48C by Shanghai Foshion Medical Instruments Co., Ltd. — Product Code KLC

K071353 is an FDA 510(k) premarket notification submitted by Shanghai Foshion Medical Instruments Co., Ltd. for the device "FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48C". The FDA issued a decision of Substantially Equivalent on December 14, 2007. The device falls under product code KLC (Chair, Dental, With Operative Unit), a Class I device regulated under 21 CFR 872.6250.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2007
Date Received
May 15, 2007
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

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

FDA data resources