Foshion Chair Mounted Dental, Model FJ48C

FDA 510(k) K071353 · Shanghai Foshion Medical Instruments Co., Ltd.

Substantially Equivalent

510(k) numberK071353

Submission

Device name
Foshion Chair Mounted Dental, Model FJ48C
Applicant
Shanghai Foshion Medical Instruments Co., Ltd.
Leola, PA, US
Received
May 15, 2007
Decision date
December 14, 2007
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KLC – Chair, Dental, With Operative Unit
Device class
Class I (low risk)
Regulation
21 CFR 872.6250
Specialty
Dental

Other 510(k)s with product code KLC

510(k)DeviceApplicantDecision
K233921Luvis Chair (LC700C)KLC · Traditional Dentis Co., Ltd.09/06/2024SE
K151987DCI Edge Dental Chair with Operative UnitKLC · Traditional Dci06/01/2016SE
K971063Optima Plus E Dental Chair; a Dental Chair; Excel ChairKLC · Traditional King Dental Corp.06/03/1997SE
K963209Prostyle CompactKLC · Traditional Planmeca Oy10/24/1996SE
K942870Ultima 2 Dental ChairKLC · Traditional Dentech Corp.02/27/1995SE
K940950Kavo Systematica 1060KLC · Traditional Kavo America12/29/1994SE
K925567E 4000 Dental Operating ChairKLC · Traditional Dentalez Group03/10/1994SE
K925119A-Dec 1040 ChairKLC · Traditional A-Dec, Inc.01/31/1994SE
K923534PM2002 ProlineKLC · Traditional Planmeca USA, Inc.01/31/1994SE
K925325A-Dec 2185 Doctor's UnitKLC · Traditional A-Dec, Inc.12/09/1993SE

Questions and answers

When was Foshion Chair Mounted Dental, Model FJ48C cleared by the FDA?

Foshion Chair Mounted Dental, Model FJ48C (K071353) received a 510(k) decision of Substantially Equivalent on December 14, 2007, 213 days after the submission was received.

What is the product code of K071353?

The FDA product code is KLC – Chair, Dental, With Operative Unit, a Class I (low risk) device regulated under 21 CFR 872.6250.