FDA.reportPublic FDA data

MC12 motorcord

Primary DI
04582227381026
Brand
MC12 motorcord
Company
OSADA ELECTRIC CO.,LTD.
Model
MC12
Catalog number
50298
Published
2016-09-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04582227381026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04582227381026045822273810264582227381026

GMDN Terms#

Term, Definition table
TermDefinition
Remotely-driven surgical/dental system drive cableA flexible device for transmitting rotational power from a remote surgical or dental drilling system motor/control unit to the drilling handpiece. The drive is designed so that the handpiece can be flexibly manipulated by the operator (the surgeon or dentist). The design is typically based on a rotating metal spun spiral cable within a protective sheath; this is commonly known as a Bowden cable. This is a reusable device.

Sterilization Methods#

Method table
Method
Liquid Chemical

Regulatory Flags#

DUNS number
690713813
Device count
1
Premarket exempt
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04582227353498ST45ST45567312020-03-19
04580406861000SH42SH42557412016-09-29
04580406869884CSR20CSR20563262018-06-07
04580406869891CSR32CSR32563272018-06-07
04580406869921WD-5WD-5563302018-06-07
04580406869945JCH-1JCH-1563322018-06-07
04580406869952JCH-2JCH-2563332018-06-07
04580406869969PCH-1PCH-1563352018-06-07
04580406869976ACH-1ACH-1563362018-06-07
04580406870781WCH-1WCH-1564042018-09-28
04582227341341CH24B contra headCH24B058322016-09-29
04582227341457SRH reciprocating HPSRH500632016-09-20
04582227341464SOH oscillating saw HPSOH756862016-09-20
04582227341563CH07 contra headCH07417672016-09-29
04582227341570CH09 contra headCH09785262016-09-29
04582227341587CH11B contra headCH11B400982016-09-29
04582227341594CH17 contra headCH17700492016-09-29
04582227341846CS132 contra shankCS132388492016-09-29
04582227341877CS031 contra shankCS031785402016-09-29
04582227341884CS032 contra shankCS032378832016-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00858466005257ENDOMAXDENTAMERICA, INC.EKX2026-04-22
00858466005240ENDOMAXDENTAMERICA, INC.EKX2026-04-21
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
10194665008529A-decA-DEC, INC.EKX2026-02-19
10194665008550A-decA-DEC, INC.EKX2026-02-19
09010522002513SmartPeg Type 127Osstell ABEKX2026-02-09
09010522002537SmartPeg Type 137Osstell ABEKX2026-02-09
D100B00XSGO000000X-Smart Go Cordless endo motor with integrated apex locatorFORUM ENGINEERING TECHNOLOGIES (96) LTD.EKX2026-01-23
D100B00XSGOAC0006X-Smart® Go Contra-angle (6:1)FORUM ENGINEERING TECHNOLOGIES (96) LTD.EKX2026-01-23
D100B00XSGOAC0007X-Smart® Go Protective silicone sleeveFORUM ENGINEERING TECHNOLOGIES (96) LTD.EKX2026-01-23
D100BSPXSGOAC0005X-Smart® Go Power bankFORUM ENGINEERING TECHNOLOGIES (96) LTD.EKX2026-01-23
09010522002674MEGA ISQ II InstrumentOsstell ABEKX2025-09-26
00860011518334InnerView® System Smart Tips Perimetrics, Inc.EKX2025-07-31
09010522002575Osstell SmartPeg Type 113Osstell ABEKX2025-03-27
09010522002599Osstell SmartPeg Type 114Osstell ABEKX2025-03-27
09010522002612Osstell SmartPeg Type 115Osstell ABEKX2025-03-27
09010522002483SmartPeg Type 117Osstell ABEKX2024-05-15