510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K071353Substantially Equivalent

Foshion Chair Mounted Dental, Model Fj48c

Shanghai Foshion Medical Instruments Co., Ltd., Leola PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K071353 is the FDA 510(k) clearance record for FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48C, a class I device, cleared for Shanghai Foshion Medical Instruments Co., Ltd. on under FDA product code KLC (Chair, Dental, With Operative Unit). FDA records list one 510(k) clearance for Shanghai Foshion Medical Instruments Co., Ltd. As of , FDA records show no recalls naming K071353.

Clearance record

Decision date
Received
(213 days to decision)
Product code
KLC Chair, Dental, With Operative Unit
Regulation
21 CFR 872.6250
Device class
Class I
Review panel
Dental
Applicant
Shanghai Foshion Medical Instruments Co., Ltd. 342 E Main St., Suite 211, Leola PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KLC

Trailing 12 months

FDA records hold no clearances under product code KLC in the trailing twelve months.

FDA records show no clearances under product code KLC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KLC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260