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
08809918260054LW Narrow Solid AbutmentLWNSA4014F2026-10-22
08809918260085LW Narrow Solid AbutmentLWNSA4015F2026-10-22
08809918259713LW OSS Abutment Lab AnalogLWOLA452026-10-13
08809918259720LW OSS Abutment Lab AnalogLWOLA552026-10-13
08809918261693LW Narrow Angled AbutmentLWNAA40225FHACS2026-08-13
08809918261815LW Narrow Angled AbutmentLWNAA40225FNCS2026-08-13
08809918262416LW Narrow Angled AbutmentLWNAA40425FHACS2026-08-13
08809918262539LW Narrow Angled AbutmentLWNAA40425FNCS2026-08-13
08809918263130LW Narrow Angled AbutmentLWNAA45225FHACS2026-08-13
08809918263253LW Narrow Angled AbutmentLWNAA45225FNCS2026-08-13
08809918263857LW Narrow Angled AbutmentLWNAA45425FHACS2026-08-13
08809918263970LW Narrow Angled AbutmentLWNAA45425FNCS2026-08-13
08809918255203LW Narrow Pre-milled AbutmentLWNDPA1040HDB2024-12-18
08809918255210LW Narrow Pre-milled AbutmentLWNDPA1040HDBS2024-12-18
08809918255227LW Narrow Pre-milled AbutmentLWNDPA1040HMX2024-12-18
08809918255234LW Narrow Pre-milled AbutmentLWNDPA1040HMXS2024-12-18
08809918255241LW Narrow Pre-milled AbutmentLWNDPA1040NDB2024-12-18
08809918255258LW Narrow Pre-milled AbutmentLWNDPA1040NDBS2024-12-18
08809918255265LW Narrow Pre-milled AbutmentLWNDPA1040NMX2024-12-18
08809918255272LW Narrow Pre-milled AbutmentLWNDPA1040NMXS2024-12-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03701045246398KONTACTBIOTECH DENTALNDP2026-10-26
03701045279471KONTACTBIOTECH DENTALNDP2026-10-26
03701045279488KONTACTBIOTECH DENTALNDP2026-10-26
03701045279495KONTACTBIOTECH DENTALNDP2026-10-26
03701045279501KONTACTBIOTECH DENTALNDP2026-10-26
03701045279518KONTACTBIOTECH DENTALNDP2026-10-26
03701045279525KONTACTBIOTECH DENTALNDP2026-10-26
03701045279532KONTACTBIOTECH DENTALNDP2026-10-26
03701045279549KONTACTBIOTECH DENTALNDP2026-10-26
03701045279556KONTACTBIOTECH DENTALNDP2026-10-26
03701045279563KONTACTBIOTECH DENTALNDP2026-10-26
03701045279570KONTACTBIOTECH DENTALNDP2026-10-26
03701045279587KONTACTBIOTECH DENTALNDP2026-10-26
03701045279594KONTACTBIOTECH DENTALNDP2026-10-26
03701045279600KONTACTBIOTECH DENTALNDP2026-10-26
03701045279617KONTACTBIOTECH DENTALNDP2026-10-26
03701045279624KONTACTBIOTECH DENTALNDP2026-10-26
03701045279631KONTACTBIOTECH DENTALNDP2026-10-26
03701045279648KONTACTBIOTECH DENTALNDP2026-10-26
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05397311032819Angled DriverHADER SOLUTIONS & DISTRIBUTION LIMITEDNDP2026-10-26
05397311032826Straight DriverHADER SOLUTIONS & DISTRIBUTION LIMITEDNDP2026-10-26
05397311032833SCS DriverHADER SOLUTIONS & DISTRIBUTION LIMITEDNDP2026-10-26
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