FDA.reportPublic FDA data

Adapter-1

Primary DI
08800021123144
Brand
Adapter-1
Company
MCT Bio
Model
Adapter-1
Catalog number
Adapter-1
Device description
Adapter 1Adapter for ratchet
Published
2024-07-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800021123144PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800021123144088000211231448800021123144

GMDN Terms#

Term, Definition table
TermDefinition
Dental power tool handpiece motorless componentA component of a dental power tool handpiece designed to connect between a dental power tool motor and an endpiece to transfer mechanical energy from the motor to the endpiece during a dental surgical procedure. It may be in the form of a torque multiplier, adapter, or motorless handpiece. Neither the motor nor the endpiece is included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+82313337373mct@mctbio.com

Regulatory Flags#

DUNS number
694484789
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800021124066SRA-01SRA-01SRA-012024-07-18
08800021124127SRG-IOSRG-IOSRG-IO2024-07-18
08800021124134SRG-SHSRG-SHSRG-SH2024-07-18
08800021124141SRG-HSRG-HSRG-H2024-07-18
08800021124301SRG-3INSRG-3INSRG-3IN2024-07-18
08800021124325SRG-NANSRG-NANSRG-NAN2024-07-18
08800021124332SRG-NANSRG-NANSRG-NAN2024-07-18
08800021124356SRG-NTRSRG-NTRSRG-NTR2024-07-18
08800021124363SRG-NTWSRG-NTWSRG-NTW2024-07-18
08800021124424SRG-BLRPSRG-BLRPSRG-BLRP2024-07-18
08800021124431SRG-BLNPSRG-BLNPSRG-BLNP2024-07-18
08800021124479SRD-02SRD-02SRD-022024-07-18
08800021125483PLD-1.8PLD-1.8PLD-1.82024-07-18
08800021123168Adapter-AAdapter-AAdapter-A2024-07-17
08800021123175Adapter-HAdapter-HAdapter-H2024-07-17
08800021123243BEC-2.6BEC-2.6BEC-2.62024-07-17
08800021123267BEC-3.4BEC-3.4BEC-3.42024-07-17
08800021123274BEC-3.8BEC-3.8BEC-3.82024-07-17
08800021123281BEC-4.3BEC-4.3BEC-4.32024-07-17
08800021124097FRW-01FRW-01FRW-012024-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800313235715SQ AXEL Guide CountersinkDENTIS CO. ,LTDNDP2026-07-09
08800313235722SQ AXEL Guide CountersinkDENTIS CO. ,LTDNDP2026-07-09
08800313235739SQ AXEL Guide CountersinkDENTIS CO. ,LTDNDP2026-07-09
08800313235746SQ AXEL Guide CountersinkDENTIS CO. ,LTDNDP2026-07-09
08800313235753SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235760SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235777SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235784SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235791SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235807SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235814SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235821SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235838SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235845SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235852SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235869SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235876SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235883SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235890SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235906SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235913SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235920SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235937SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235944SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235951SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235968SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235975SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235982SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235999SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313236002SQ Guide Long DrillDENTIS CO. ,LTDNDP2026-07-09