FDA.reportPublic FDA data

Drill Stopper S2

Primary DI
08809918259881
Brand
Drill Stopper S2
Company
Ossvis Co., Ltd.
Model
HDS08CS2
Device description
Dental Implant Surgical Instrument - Drill Stopper
Published
2024-10-25
Public version status
Update
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
08809918259881PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809918259881088099182598818809918259881

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument/implant depth limiterA device designed to limit the depth of insertion of a surgical instrument (e.g., a drill bit or a reamer), a trial implant, or an implant. It may be used as a stand-alone device or it may be attached to another device to control insertion depth, typically to prevent insertion below the surgical field of interest thereby avoiding damage to tissue behind or below target structures. It is typically made of high-grade stainless steel and/or synthetic material and is available in a variety of shapes and lengths. 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
07290109748054Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290109748061Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290109748078Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290109748085Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290109748092Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290109748108Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290109748115Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290116660882Surgical ToolsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNDP2026-07-12
07290116660899Surgical ToolsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNDP2026-07-12
07290116660981Surgical ToolsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNDP2026-07-12
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