FDA.reportPublic FDA data

Stopper Drill

Primary DI
08806388242214
Brand
Stopper Drill
Company
Megagen Implant Co. Ltd
Model
R2DS4309
Catalog number
R2DS4309
Device description
Common Ø4.3/ L=9
Published
2015-06-23
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
08806388242214PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806388242214088063882422148806388242214

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

Regulatory Flags#

DUNS number
687388178
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08806388226221BCP EAGLE EYEMGSB0802MGSB08022015-06-29
08806388226238BCP EAGLE EYEMGSB0805MGSB08052015-06-29
08806388226245BCP EAGLE EYEMGSB0810MGSB08102015-06-29
08806388226252BCP EAGLE EYEMGSB0820MGSB08202015-06-29
08806388271504Mega-Oss BovineTMIOSG025IOSG0252018-10-15
08806388271511Mega-Oss BovineTMIOSG050IOSG0502018-10-15
08806388271528Mega-Oss BovineTMIOSG100IOSG1002018-10-15
08806388271535Mega-Oss BovineTMIOSG200IOSG2002018-10-15
08806388271542Mega-Oss BovineTMIOSG500IOSG5002018-10-15
08806388271559Mega-Oss BovineTMIOLG050IOLG0502018-10-15
08806388271566Mega-Oss BovineTMIOLG100IOLG1002018-10-15
08806388271573Mega-Oss BovineTMIOLG200IOLG2002018-10-15
08809977452445BLUEDIAMOND IMPLANTBDC410506C2026-09-04
08809977452469BLUEDIAMOND IMPLANTBDC410506DC2026-09-04
08809977452568BLUEDIAMOND IMPLANTBDC410706C2026-09-04
08809977452582BLUEDIAMOND IMPLANTBDC410706DC2026-09-04
08809977452681BLUEDIAMOND IMPLANTBDC410904C2026-09-04
08809977452704BLUEDIAMOND IMPLANTBDC410904DC2026-09-04
08809977452728BLUEDIAMOND IMPLANTBDC410906C2026-09-04
08809977452742BLUEDIAMOND IMPLANTBDC410906DC2026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290116661322Surgical ToolsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNDP2026-10-11
00810157315762MUA PEEK Comfort CapParagon Implant Mfg., LLCNDP2026-10-09
06942799001100SHINING 3D®Shining 3D Tech Co., Ltd.NDP2026-10-09
07899878068143NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-10-09
07899878068150NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-10-09
07899878068167NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-10-09
07899878068174NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-10-09
06009544052876N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052883N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052890N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052906N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052920N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052937N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053071N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053088N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053095N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053101N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053118N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053125N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053132N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053149N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053156N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053163N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053248N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053293N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053347N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053354N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053361N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053415N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
07640149886726TRITRI Dental Implants Int. AGNDP2026-10-06