FDA.reportPublic FDA data

NAC-F

Primary DI
04560224990564
Brand
NAC-F
Company
NAKANISHI INC.
Model
NAC-F
Published
2020-06-25
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
EKXHandpiece, direct drive, ac-powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKXHandpiece, Direct Drive, Ac-PoweredDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04589551382996Direct MarkingGS10
04560224990564PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04589551382996045895513829964589551382996
04560224990564045602249905644560224990564

GMDN Terms#

Term, Definition table
TermDefinition
Dental power tool system handpiece, line-poweredA hand-held, mains electricity (AC-powered) dental device that includes a chuck or collet for attaching a dental endpiece (e.g., drill bit, bur, reamer, saw blade, polishing disk) intended to be used in dentistry to bore/excavate bones, teeth, and tough tissues. It is powered by a low-voltage electric micro-motor (e.g., 24 volt) that is an integral part of the device; the endpiece(s) are not included. It is typically connected through the dental delivery system or a freestanding independent control unit. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
690710546
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
04589551388929VA170LUX-SCVA170LUX-SC2026-02-13
04589551388936VA170-SCVA170-SC2026-02-13
04589551388981Potentiometer SetPotentiometer Set2026-02-13
04589551389452VariosG162026-02-13
04589551383900VariosScaling G16 Pack2026-02-13
04589551389476Perio Kit APerio Kit A2026-02-13
04589551389483VA170VA1702026-02-13
04560264577763VA2-LUX-HP TiVA2-LUX-HP Ti2026-02-13
04589551387168Tip Cover LTip Cover L2026-01-21
04589551387151Tip Cover STip Cover S2026-01-21
04589551382828E TIP WRENCHE TIP WRENCH2026-01-21
04589551387144VariosCR-12026-01-21
04560264579958CLA-10CLA-102026-01-21
045895513889743 Mode Select Switch3 Mode Select Switch2026-01-21
04589551383863VariosG12022-12-13
04589551383870VariosG42022-12-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800313230000ChecQPEGDENTIS CO. ,LTDEKX2026-03-03
10194665008444A-decA-DEC, INC.EKX2026-02-19
E27668665320Midwest IMPLANT 20:1SIRONA Dental Systems GmbHEKX2026-02-19
09010522002506SmartPeg Type 127Osstell ABEKX2026-02-09
09010522002520SmartPeg Type 137Osstell ABEKX2026-02-09
06941877827809ZarcChangzhou Sifary Medical Technology Co., Ltd.EKX2026-01-05
06944835130195NIC/SUPERLINEShenzhen Superline Technology Co., Ltd.EKX2025-12-22
10817417020395AsepticoASEPTICO, INC.EKX2025-12-16
10817417020401AsepticoASEPTICO, INC.EKX2025-12-16
08056814270117EnDrive ADVANCED TECHNOLOGY RESEARCH A.T.R. SRLEKX2025-11-26
09010522002650Osstell Beacon InstrumentOsstell ABEKX2025-09-26
09010522002667MEGA ISQ II InstrumentOsstell ABEKX2025-09-26
00860011518327InnerView® System Smart Tips Perimetrics, Inc.EKX2025-07-31
08809455602683elements ConnectMETA SYSTEMS CO., LTD.EKX2025-06-05
08809455602720elements ConnectMETA SYSTEMS CO., LTD.EKX2025-06-05
08809455602744elements ConnectMETA SYSTEMS CO., LTD.EKX2025-06-05
08800053084123ChecQDENTIS CO. ,LTDEKX2025-03-31
08800053092494ChecQPEGDENTIS CO. ,LTDEKX2025-03-31
08800053092500ChecQPEGDENTIS CO. ,LTDEKX2025-03-31
08800053092517ChecQPEGDENTIS CO. ,LTDEKX2025-03-31
08800053092524ChecQPEGDENTIS CO. ,LTDEKX2025-03-31
08800053092531ChecQPEGDENTIS CO. ,LTDEKX2025-03-31
08800053092548ChecQPEGDENTIS CO. ,LTDEKX2025-03-31
08800053092555ChecQPEGDENTIS CO. ,LTDEKX2025-03-31
08800053092562ChecQPEGDENTIS CO. ,LTDEKX2025-03-31
08800053092579ChecQPEGDENTIS CO. ,LTDEKX2025-03-31
08800053092586ChecQPEGDENTIS CO. ,LTDEKX2025-03-31
08800053092593ChecQPEG DriverDENTIS CO. ,LTDEKX2025-03-31
08800266943897ChecQPEGDENTIS CO. ,LTDEKX2025-03-31
09010522002551Osstell SmartPeg Type 112Osstell ABEKX2025-03-27