FDA.reportPublic FDA data

Surgical Drive System

Primary DI
06971119540838
Brand
Surgical Drive System
Company
Guangdong JINME Medical Technology Co., Ltd.
Model
ES90
Device description
Surgical Drive System
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
DZIDrill, Bone, Powered
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZIDrill, Bone, PoweredDental2
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including HandpieceEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240340000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240340000Surgical Drive System (Model: ES70, ES90, E8)Guangdong Jinme Medical Technology Co., Ltd.2024-07-18DZI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971119540838PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971119540838069711195408386971119540838

GMDN Terms#

Term, Definition table
TermDefinition
Surgical power tool system control unit, line-poweredA mains electricity (AC-powered) component of a line-powered surgical/dental power tool system intended to step down the electrical power from the mains to supply the handpiece/motor (not included), and may also be intended to regulate some of the functions of the connected power tools (e.g., speed and torque); it may be intended for single or multiple clinical applications (i.e., dedicated or non-dedicated). This device may have integrated irrigation functionality and may be operated through hand and/or foot controls.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
543260808
Device count
1
Serial number
true
Manufacturing date on label
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04589551366217P300-2A100NAKANISHI INC.ERL2026-06-26
04589551366262P300-2A120NAKANISHI INC.ERL2026-06-26
04589551366316P300-2S100NAKANISHI INC.ERL2026-06-26
04589551366361P300-2S120NAKANISHI INC.ERL2026-06-26
00821925033900DIEGOGyrus ACMI, LLCERL2024-07-25
00821925033917DIEGOGyrus ACMI, LLCERL2024-07-24
00821925034419DIEGOGyrus ACMI, LLCERL2024-07-23
07613327501292iBurSTRYKER CORPORATIONERL2021-08-12
07613327501308iBurSTRYKER CORPORATIONERL2021-08-12
00821925011441DIEGOGyrus ACMI, LLCERL2017-05-11
00821925011410DIEGOGyrus ACMI, LLCERL2016-10-12
00821925028746DiegoGyrus ACMI, LLCERL2016-10-06
10886982064721NASynthes GmbHERL2016-06-30
10886982064721NASynthes GmbHDZI2016-06-30
10886982064738NASynthes GmbHERL2016-06-30
10886982064738NASynthes GmbHDZI2016-06-30
10886982064745NASYNTHES (U.S.A.) LPDZI2016-06-30
10886982064745NASYNTHES (U.S.A.) LPERL2016-06-30
10886982064820NASYNTHES (U.S.A.) LPERL2016-06-30
10886982064820NASYNTHES (U.S.A.) LPDZI2016-06-30
10886982064844NASYNTHES (U.S.A.) LPERL2016-06-30
10886982064844NASYNTHES (U.S.A.) LPDZI2016-06-30
10886982064882NASYNTHES (U.S.A.) LPERL2016-06-30
10886982064882NASYNTHES (U.S.A.) LPDZI2016-06-30
10886982064905NASYNTHES (U.S.A.) LPDZI2016-06-30
10886982064905NASYNTHES (U.S.A.) LPERL2016-06-30
10886982064912NASynthes GmbHDZI2016-06-30
10886982064912NASynthes GmbHERL2016-06-30
10886982064929NASYNTHES (U.S.A.) LPDZI2016-06-30
10886982064929NASYNTHES (U.S.A.) LPERL2016-06-30