FDA.reportPublic FDA data

SRG-BLNP

Primary DI
08800021124431
Brand
SRG-BLNP
Company
MCT Bio
Model
SRG-BLNP
Catalog number
SRG-BLNP
Device description
Screw Remover Guide BLNP,IMPLANT RESCUE-SRG-BLNP
Published
2024-07-18
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
08800021124431PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800021124431088000211244318800021124431

GMDN Terms#

Term, Definition table
TermDefinition
Fixture/appliance dental drill bit, reusableA shaft of metal intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a manual or power tool handpiece that provides rotation. 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
08800021124479SRD-02SRD-02SRD-022024-07-18
08800021125483PLD-1.8PLD-1.8PLD-1.82024-07-18
08800021123144Adapter-1Adapter-1Adapter-12024-07-17
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