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
08800016100686Dental Implants Accesseories-Single UseCowellmedi Co.,LtdNDP2026-08-03
08800016108774Dental Implants Accesseories-ReusableCowellmedi Co.,LtdNDP2026-07-28
08800076476271T-Marker KitTruabutment Korea Co.,LtdNDP2026-07-27
D7702682153RIGHT ANGLE SCREWDRIVER FORSWEDEN & MARTINA SPANDP2026-07-27
D7702698973DRILLSWEDEN & MARTINA SPANDP2026-07-27
D7702698983DRILLSWEDEN & MARTINA SPANDP2026-07-27
D7702750843INTRAORAL SCANBODYSWEDEN & MARTINA SPANDP2026-07-27
D7702750853INTRAORAL SCANBODYSWEDEN & MARTINA SPANDP2026-07-27
03701045246374KONTACTBIOTECH DENTALNDP2026-07-24
03701045246381KontactBIOTECH DENTALNDP2026-07-24
08800076470569HS Cap SmallTruabutment Korea Co.,LtdNDP2026-07-21
08800076475830T-L Digital AnalogTruabutment Korea Co.,LtdNDP2026-07-21
08800076476042T-Marker KitTruabutment Korea Co.,LtdNDP2026-07-21
08800076476059T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476066T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476073T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476080T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476097T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476103T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476110T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476127T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476134T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476141T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476172T-Marker ScrewTruabutment Korea Co.,LtdNDP2026-07-21
08800076476219TruBite ScopeTruabutment Korea Co.,LtdNDP2026-07-21
08800076476226TruBoltTruabutment Korea Co.,LtdNDP2026-07-21
08800076476233TruBoltTruabutment Korea Co.,LtdNDP2026-07-21
08435673515131DYNAMIC ABUTMENT SOLUTIONSTALLADIUM ESPAÑA SLNDP2026-07-20
07899995235299DRIVER HANDPIECE MINI ABUT. EXT. LONGSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235305DRIVER HANDPIECE MINI ABUT. LONGSin Sistema de Implante Nacional S/ANDP2026-07-14