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

Portable Dental Operative Unit

21 CFR 872.6640 / Dental
FDA source (opens on fda.gov)

Classification record

Product code
SJH
Device name
Portable Dental Operative Unit
FDA definition
A portable dental operative unit is a device intended to serve as a base station for dental instruments and accessories, delivering utilities such as compressed air, water, suction, and power to handheld dental instruments. The device is designed for use in non-permanent healthcare environments, including dental clinics, hospitals, mobile clinics, long-term care facilities, patient residences, schools, correctional facilities, military or humanitarian field settings, and similar settings, by dental professionals.
Regulation
21 CFR 872.6640
Device class
Class I
Review panel
Dental
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code SJH

By decision year
1 clearance under product code SJH with a decision year between 2026 and 2026, 2026 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code SJH by decision year
YearClearances
20261

Applicants with the most clearances

Product code SJH
Applicants holding the most 510(k) clearances under product code SJH
ApplicantClearances
Lakong Medical Devices Co., Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code