510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K254009Substantially Equivalent

Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV)

Lakong Medical Devices Co., Ltd., Dongguan, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

Clearance record

Decision date
Received
(269 days to decision)
Product code
SJH Portable Dental Operative Unit
Regulation
21 CFR 872.6640
Device class
Class I
Review panel
Dental
Applicant
Lakong Medical Devices Co., Ltd. #13 Jingci Rd., Shilong, Dongguan, CN
510(k) summary
Statement
Third party review
No

Clearances, product code SJH

Trailing 12 months
1 clearance under product code SJH in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SJH, 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 20261
October 20260