X-SG93

Primary DI
04589551382453
Brand
X-SG93
Company
NAKANISHI INC.
Model
X-SG93
Published
2022-02-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KMWHANDPIECE, ROTARY BONE CUTTING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMWHandpiece, Rotary Bone CuttingDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211584000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211584000Oral Surgery ContraNakanishi, Inc.2021-08-19KMW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04560264557116Direct MarkingGS10
04589551382453PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04560264557116045602645571164560264557116
04589551382453045895513824534589551382453

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
690710546
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04589551366583Sterile Cutting ToolUBS-RD70C2-082026-05-22
04589551366590Sterile Cutting ToolUBS-RD70C2-072026-05-22
04589551366606Sterile Cutting ToolUBS-RD50C2-082026-05-22
04589551366613Sterile Cutting ToolUBS-RD50C2-072026-05-22
04560264564213iProphy mobileiProphy mobile Motor2020-06-18
04589551392940WrenchWrench2026-04-27
04589551389186VS4-LED-HPSCVS4-LED-HPSC2026-04-23
04589551389216FC-86FC-862026-04-23
04589551390960VarioSurg 4 (120V)VarioSurg 4 (120V)2026-04-23
04589551390977VarioSurg 4 w/o FC (120V)VarioSurg 4 w/o FC (120V)2026-04-23
04589551393398FC-78FC-782026-04-23
04589551389001CR-30CR-302026-04-20
04589551391462M-RE2M-RE22026-04-20
04589551391479M-ST1M-ST12026-04-20
04589551391486M-OC1RM-OC1R2026-04-20
04589551391493M-OC1LM-OC1L2026-04-20
04589551393589SG12SG122026-04-20
04560264510913Ti-Max XX57L2020-06-05
04560264510920Ti-Max XX572020-06-05
04560264510937Ti-Max XX35L2020-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810126043153SM7 US ( Complete Set )HIOSSEN, INC.KMW2026-01-09
00810126043160S200EML (Contra) Dental Surgery Hand PieceHIOSSEN, INC.KMW2026-01-09
04589551388813SG20MNAKANISHI INC.KMW2025-08-28
04589551388820X-SG20MLNAKANISHI INC.KMW2025-08-28
04560264576940SG20MNAKANISHI INC.KMW2025-08-28
04560264576957X-SG20MLNAKANISHI INC.KMW2025-08-28
J021101008011S-8 RW & H Dentalwerk Bürmoos GmbHKMW2025-08-26
J021101008021S-8 OW & H Dentalwerk Bürmoos GmbHKMW2025-08-26
J021101008031S-8 SW & H Dentalwerk Bürmoos GmbHKMW2025-08-26
J021101008010S-8 RW & H Dentalwerk Bürmoos GmbHKMW2025-08-26
J021101008020S-8 OW & H Dentalwerk Bürmoos GmbHKMW2025-08-26
J021101008030S-8 SW & H Dentalwerk Bürmoos GmbHKMW2025-08-26
06974267891104COXOFoshan COXO Medical Instrument Co.,Ltd.KMW2024-07-04
06974267891067COXOFoshan COXO Medical Instrument Co.,Ltd.KMW2024-03-30
J021300320021WS-75 LG surgical handpiece, 20:1, MISW & H Dentalwerk Bürmoos GmbHKMW2023-07-11
J021300320020WS-75 LG surgical handpiece, 20:1, MISW & H Dentalwerk Bürmoos GmbHKMW2023-07-11
04589551382446X-SG93LNAKANISHI INC.KMW2022-02-17
04589551382460X-SG25LNAKANISHI INC.KMW2022-02-17
04560264557109X-SG93LNAKANISHI INC.KMW2022-02-17
04560264557116X-SG93NAKANISHI INC.KMW2022-02-17
04560264557130X-SG25LNAKANISHI INC.KMW2022-02-17
D762KITBOPR000Implant-OneImplant Logistics, Inc.KMW2021-05-12
D762KITBOPR001Implant-OneImplant Logistics, Inc.KMW2021-05-12
00840117305151Plastic Overbed Table, H Base, Silver Vein, GreyDynarex CorporationKMW2021-04-22
00840117305168Plastic Overbed Table, H Base, Silver Vein, CherryDynarex CorporationKMW2021-04-22
00840117305182Plastic Overbed Table, H Base, Silver Vein, Mahogany Dynarex CorporationKMW2021-04-22
00814913029603SM3HIOSSEN, INC.KMW2021-01-20
J021304110001S-16 Surgical Handpiece 1:2W & H Dentalwerk Bürmoos GmbHKMW2020-09-15
J02130095000Zygoma SZ-75W & H Dentalwerk Bürmoos GmbHKMW2020-07-30
00845694094290OsteoMedOSTEOMED LLCKMW2020-04-28