FDA.reportPublic FDA data

Dental Handpiece

Primary DI
06971119541019
Brand
Dental Handpiece
Company
Guangdong JINME Medical Technology Co., Ltd.
Model
W15LW
Device description
Dental Handpiece
Published
2025-07-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EFBHandpiece, Air-Powered, Dental
EGSHandpiece, Contra- And Right-Angle Attachment, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFBHandpiece, Air-Powered, DentalDental1
EGSHandpiece, Contra- And Right-Angle Attachment, DentalDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240337000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240337000Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)Guangdong Jinme Medical Technology Co., Ltd.2024-11-13EFB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971119541019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971119541019069711195410196971119541019

GMDN Terms#

Term, Definition table
TermDefinition
Dental surgical power tool motorized handpiece/set, electricAn electrically-powered one-piece device or modular device collection designed to accept an endpiece(s) [e.g., drill bit, saw blade] for drilling, cutting, polishing, and/or inserting procedures involving bones and tough tissues during a dental surgical procedure. It includes an electric motor and the appropriate attachments (e.g., angle adaptor, torque multiplier) at its distal end for connection of the endpieces and may include a rechargeable battery or a control unit; the endpieces are not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
543260808
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971119541323Dental chair and accessoriesS6102026-03-30
06971119541316Dental chair and accessoriesS6902025-07-15
06971119540968Intra Oral ScannerECO-SCANNER 12025-07-15
06971119540975Intra Oral ScannerECO-SCANNER 22025-07-15
06971119542399Intra Oral CameraECO-CAMERA 012025-09-18
06971119542405Intra Oral CameraECO-CAMERA 022025-09-18
06971119541897Air compressor Air compressor2025-07-23
06971119541903Testing machineHP Tester2025-07-23
06971119540036Dental Low-Speed Turbine Handpiece LN2025-07-15
06971119540135Dental High-Speed Turbine Handpiece SUQP2025-07-15
06971119540142Dental High-Speed Turbine Handpiece TUQP2025-07-15
06971119540159Dental High-Speed Turbine Handpiece SUQ2025-07-15
06971119540166Dental High-Speed Turbine Handpiece TUQ2025-07-15
06971119540173Dental High-Speed Turbine Handpiece SUP2025-07-15
06971119540180Dental High-Speed Turbine Handpiece TUP2025-07-15
06971119540197Dental High-Speed Turbine Handpiece SP2025-07-15
06971119540203Dental High-Speed Turbine Handpiece TP2025-07-15
06971119540227Dental High-Speed Turbine Handpiece SU2025-07-15
06971119540234Dental High-Speed Turbine Handpiece TU2025-07-15
06971119540258Dental High-Speed Turbine Handpiece S2025-07-15

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Primary DI, Brand, Company table
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07613353240134PERIO-FLOW HandpieceE.M.S. Electro Medical Systems S.A.EFB2026-07-14
07613353312558AIR-FLOW® PLUS handy 3.0 PERIO handpieceE.M.S. Electro Medical Systems S.A.EFB2026-07-14
07613353344238PERIO-FLOW HandpieceE.M.S. Electro Medical Systems S.A.EFB2026-07-14
00840456222843JMUJMU DENTAL, INCEFB2026-06-25
00840456222850JMUJMU DENTAL, INCEFB2026-06-25
00810021439778DCI EdgeDCI International, LLCEFB2026-06-01
00810021439785DCI EdgeDCI International, LLCEFB2026-06-01
D77142130771Dental CityICP, INC.EGS2026-05-27
D77142131771Dental CityICP, INC.EGS2026-05-27
D77142132771Dental CityICP, INC.EGS2026-05-27
D77142133771Dental CityICP, INC.EGS2026-05-27
07640397422028Statcare sprayDent4You AGEFB2026-04-24
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00304040194348Henry ScheinHENRY SCHEIN, INC.EGS2025-12-15
00304040194355Henry ScheinHENRY SCHEIN, INC.EGS2025-12-15
00304040194362Henry ScheinHENRY SCHEIN, INC.EGS2025-12-15
00304040194386Henry ScheinHENRY SCHEIN, INC.EGS2025-12-15
J021020835001MCA-RM-BCW & H Dentalwerk Bürmoos GmbHEFB2025-12-02
J0071600436001USA1PM 1:2Bien-Air Dental SAEFB2025-10-13
J0071600052001USA1PM 1:1 EXT SPRAYBien-Air Dental SAEFB2025-10-10
J0071600692001USA1CA 20:1 L MICRO-SERIESBien-Air Dental SAEFB2025-10-10
J0071601136001USA1CA NOVA 1:1L MSBien-Air Dental SAEFB2025-10-10
J0071601138001USA1CA NOVA 1:5L MSBien-Air Dental SAEFB2025-10-10
07613353342067AIR-FLOWE.M.S. Electro Medical Systems S.A.EFB2025-07-07
07613353342074AIR-FLOWE.M.S. Electro Medical Systems S.A.EFB2025-07-07
D66207043102302Patterson®PATTERSON DENTAL SUPPLY, INC.EGS2024-11-11
D6620704340920Patterson®PATTERSON DENTAL SUPPLY, INC.EGS2024-11-11