FDA.reportPublic FDA data

Dental High-speed Turbine Handpiece

Primary DI
06971119540012
Brand
Dental High-speed Turbine Handpiece
Company
Guangdong JINME Medical Technology Co., Ltd.
Model
T, S, TU, SU, TP, SP, TUQ, TUP, SUP, SUQ, TUQP, SU
Device description
The Dental High-speed Turbine Handpiece is the dental clinic, hospital treatment for patients with tooth disease tools, which is an effective instrument for drilling, grinding, repairing. It composed of handpiece and a connector.The handle is slide-proof, comfortable and easy to clean. Handpiece and adaptors can bear steam disinfection at 135°C. The head angle can provide better operational vision and angle so that work efficiency can be improved. Cartridges have high precision when rotating; cartridges have low noise and high efficiency. The scope of application: for dental professional use only.Lubricant should be used during routine maintenance (e.g. after each patient use and prior to sterilization).In order to avoid the risk, user must buy and use specified lubricant type “PANA SPRAY Plus” manufactured by NAKANISHI INC (cleared in K163483).
Published
2018-01-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true

Product Codes#

Code, Name table
CodeName
EFBHandpiece, Air-Powered, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFBHandpiece, Air-Powered, DentalDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170229000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170229000Dental High-speed Turbine HandpieceGuangdong Jinme Medical Technology Co., Ltd.2017-11-08EFB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971119540012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971119540012069711195400126971119540012

GMDN Terms#

Term, Definition table
TermDefinition
Dental power tool system handpiece, pneumaticA hand-held dental device that includes a chuck for attaching a rotary dental endpiece (e.g., drill bits, burs, reamers) intended to be used in dentistry to bore/excavate bones, teeth, and tough tissues. The device incorporates a small turbine motor normally driven by compressed air, and which typically has a built-in water spray for cooling the rotating device; the endpiece(s) are not included. The handpiece is typically connected through the dental delivery system or a freestanding independent system. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
543260808
Device count
1
Lot or batch
true
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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