Portable Dental Unit

Primary DI
06975220031100
Brand
Portable Dental Unit
Company
Lakong Medical Devices Co., Ltd.
Model
OMC 2375CV
Device description
The Portable Dental Unit is intended to supply power and serve as a base for dental devices andaccessories. This device delivers air, water, vacuum, and electricity to handheld instruments, foruse in dental clinics and hospitals. It is designed to be used by professional dental practitioners.
Published
2026-10-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
SJHPortable Dental Operative Unit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SJHPortable Dental Operative Unit

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K254009000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K254009000Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV)Lakong Medical Devices Co., Ltd.2026-09-10SJH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975220031100PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975220031100069752200311006975220031100

GMDN Terms#

Term, Definition table
TermDefinition
Dental delivery system instrument unit, electricA mains electricity (AC-powered) device designed to make available the necessary instruments/equipment and power to deliver dental treatment to a patient. It consists of a platform for the display of a selection of powered dental instruments (e.g., motor handpiece, scaler, suction, air/water spray), sometimes with a control panel for setting various operating parameters; it may be portable or mounted. The device is commonly referred to as a dental unit or dental operative unit and is intended to be operated by a healthcare professional in a medical facility.

Regulatory Flags#

DUNS number
420716346
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975220031001Portable Dental UnitPC 26302026-10-20
06975220031070Portable Dental UnitMC 3600CV2026-10-20
06975220031162Dental UnitMP2000-550LED-2.02026-10-20
06975220031179Dental UnitLP2100-550LED-2.02026-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975220031001Portable Dental UnitLakong Medical Devices Co., Ltd.SJH2026-10-20
06975220031070Portable Dental UnitLakong Medical Devices Co., Ltd.SJH2026-10-20