510(k) clearances

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

Lakong Medical Devices Co., Ltd. · Dental

K254009Substantially EquivalentTraditionalSJH
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Third party flag
N
City
Dongguan
Advisory committee description
Dental
Address 1
#13 Jingci Rd., Shilong
Statement or summary
Statement
Product code
SJH
Zip code
523326
Applicant
Lakong Medical Devices Co., Ltd.
Decision date
2026-09-10
Decision code
SESE
Country code
CN
Device name
Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV)
Advisory committee
DE
Contact
Zhongliang Wang
K number
K254009
Date received
2025-12-15
Review advisory committee
DE
Postal code
523326
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Portable Dental Operative Unit
Medical specialty description
Dental
Regulation number
872.6640
Device class
1
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.