FDA.reportPublic FDA data

Drill Stopper

Primary DI
08809918259942
Brand
Drill Stopper
Company
Ossvis Co., Ltd.
Model
HDS05CSI
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
08809918259942PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809918259942088099182599428809918259942

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
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
08809918249868LW Narrow Implant SLALWNF3508S2024-08-13
08809918249875LW Narrow Implant SLALWNF3510S2024-08-13
08809918249882LW Narrow Implant SLALWNF3511S2024-08-13
08809918249899LW Narrow Implant SLALWNF3513S2024-08-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640149886726TRITRI Dental Implants Int. AGNDP2026-10-06
07640149886733TRITRI Dental Implants Int. AGNDP2026-10-06
07640149886757TRITRI Dental Implants Int. AGNDP2026-10-06
07640149886764TRITRI Dental Implants Int. AGNDP2026-10-06
06009544030287N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052401N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052418N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052425N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052432N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052517N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052524N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052531N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052548N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052555N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052630N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052647N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052654N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052661N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052678N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052685N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052692N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052708N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052715N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052722N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052739N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052746N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052753N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052760N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052777N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544053224N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01