FDA.reportPublic FDA data

iSD900

Primary DI
04560264573291
Brand
iSD900
Company
NAKANISHI INC.
Model
iSD900
Published
2020-11-14
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
EKXHandpiece, direct drive, ac-powered

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110278000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110278000CORDLESS PROSTHODONTIC SCREWDRIVER WITH TORQUE CALIBRATION SYSTEM, MODEL ISD900Nakanishi, Inc.2012-02-15EKX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04560264573291PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04560264573291045602645732914560264573291

GMDN Terms#

Term, Definition table
TermDefinition
Power tool torque control unitA mains electricity (AC-powered) unit that is connected to a power tool or a power tool system and used to regulate the torque effect of that power tool. This is to give the tool greater or lesser torque effect assisting in the power requirement of the intervention being carried out, e.g., a screwdriver for the insertion and tightening of orthopaedic fixation screws, tooth prosthesis anchoring screws.

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
04560264565845TI-MAX X CONTRA/HPX95L2020-06-12
04560264565869TI-MAX X CONTRA/HPX25L2020-06-12
04560264565876TI-MAX X CONTRA/HPX20L2020-06-12
04560264565883TI-MAX X CONTRA/HPX15L2020-06-12
04560264565906TI-MAX X CONTRA/HPX952020-06-12
04560264565913TI-MAX X CONTRA/HPX852020-06-12
04560264578180S-MAX M CONTRA/HPM952021-04-12
04560264578203S-MAX M CONTRA/HPM252021-04-12
04560264578210S-MAX M CONTRA/HPM15L2021-04-06
04560264578227S-MAX M CONTRA/HPM152021-04-06
04560264565920TI-MAX X CONTRA/HPX252020-06-26
04560264565937TI-MAX X CONTRA/HPX152020-06-26
04560264565944TI-MAX X CONTRA/HPX122020-06-26
04560264565975TI-MAX Z CONTRA/HPZ15L2020-06-27
04589551366217P300-2A100P300-2A1002026-06-26
04589551366262P300-2A120P300-2A1202026-06-26
04589551366316P300-2S100P300-2S1002026-06-26
04589551366361P300-2S120P300-2S1202026-06-26
04589551366422PD-IN-2-120PD-IN-2-1202026-06-26
04560264548459Powder Handpiece(For Prophy use)Powder Handpiece(For Prophy use)2026-06-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800313230017ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313230024ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313230031ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313230048ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313230055ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313230062ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313237429ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313237436ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313237443ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313237450ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313237467ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313237474ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313237481ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313237498ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313237504ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
06944843655932COLTENEGuilin Woodpecker Medical Instrument Co., Ltd.EKX2026-08-18
10817417020227AsepticoASEPTICO, INC.EKX2026-04-08
10817417020326AsepticoASEPTICO, INC.EKX2026-04-08
10817417020371AsepticoASEPTICO, INC.EKX2026-04-06
10817417020388AsepticoASEPTICO, INC.EKX2026-04-06
10817417020418AsepticoASEPTICO, INC.EKX2026-04-03
10817417020425AsepticoASEPTICO, INC.EKX2026-04-03
10817417020432AsepticoASEPTICO, INC.EKX2026-04-03
10817417020449AsepticoASEPTICO, INC.EKX2026-04-03
08809260475458E-CUBESaeshin Precision Co., Ltd.EKX2026-03-31
10194665008475A-decA-DEC, INC.EKX2026-02-19
10194665008482A-decA-DEC, INC.EKX2026-02-19
10194665008499A-decA-DEC, INC.EKX2026-02-19
10194665008505A-decA-DEC, INC.EKX2026-02-19
10194665008512A-decA-DEC, INC.EKX2026-02-19