FDA.reportPublic FDA data

Drill Extension

Primary DI
08809877419838
Brand
Drill Extension
Company
Ossvis Co., Ltd.
Model
HDE
Device description
Dental Implant Surgical Instrument - Drill Extension
Published
2023-12-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
08809877419838PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809877419838088098774198388809877419838

GMDN Terms#

Term, Definition table
TermDefinition
Dental drill bit extensionA device intended to be attached to the shaft of a normal dental drill bit in order to lengthen it, providing greater accessibility and/or drilling capacity during a dental procedure. It is typically made of a high-grade metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
695365503
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809918249837Steel BowlHSB2023-12-18
08809918249844Bone Tack CaseHSBTC2023-12-18
08809918209619Bone Tack CarrierHSBC2023-12-15
08809918273252LW Oss Abutment Driver EngineHLWORSE2024-10-25
08809918273269LW Oss Abutment Driver WrenchHLWORSW2024-10-25
08809918273436LW Oss Abutment Scan BodyLWOSB455HS2024-10-25
08809918273443LW Oss Abutment Scan BodyLWOSB455NS2024-10-25
08809918273450LW Oss Abutment Scan BodyLWOSB458HS2024-10-25
08809918273467LW Oss Abutment Scan BodyLWOSB458NS2024-10-25
08809918273474LW Oss Abutment Scan BodyLWOSB555HS2024-10-25
08809918273481LW Oss Abutment Scan BodyLWOSB555NS2024-10-25
08809918273498LW Oss Abutment Scan BodyLWOSB558HS2024-10-25
08809918273504LW Oss Abutment Scan BodyLWOSB558NS2024-10-25
08809918254947LW Oss Abutment Pick-up Impression CopingLWOPI45H2024-08-01
08809918254954LW Oss Abutment Pick-up Impression CopingLWOPI45HS2024-08-01
08809918254961LW Oss Abutment Pick-up Impression CopingLWOPI45N2024-08-01
08809918254978LW Oss Abutment Pick-up Impression CopingLWOPI45NS2024-08-01
08809918254985LW Oss Abutment Pick-up Impression CopingLWOPI55H2024-08-01
08809918254992LW Oss Abutment Pick-up Impression CopingLWOPI55HS2024-08-01
08809918255005LW Oss Abutment Pick-up Impression CopingLWOPI55N2024-08-01

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