FDA.reportPublic FDA data

Stopper Drill

Primary DI
08806388237296
Brand
Stopper Drill
Company
Megagen Implant Co. Ltd
Model
TANFSS2913
Catalog number
TANFSS2913
Device description
AnyRidge Internal Ø2.9/ L=13/ Straight
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
08806388237296PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806388237296088063882372968806388237296

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
08806388287857Healing AbutmentAOHS50704AOHS50704T2023-06-30
08806388287819Healing AbutmentAOHS50655AOHS50655T2023-06-08
08806388287826Healing AbutmentAOHS50657AOHS50657T2023-06-08
08806388287833Healing AbutmentAOHS50702AOHS50702T2023-06-08
08806388287840Healing AbutmentAOHS50703AOHS50703T2023-06-08
08806388287864Healing AbutmentAOHS50705AOHS50705T2023-06-08
08806388287871Healing AbutmentAOHS50707AOHS50707T2023-06-08
08806388287888Healing AbutmentAOHS60702AOHS60702T2023-06-08
08806388287895Healing AbutmentAOHS60703AOHS60703T2023-06-08
08806388287901Healing AbutmentAOHS60704AOHS60704T2023-06-08
08806388287918Healing AbutmentAOHS60705AOHS60705T2023-06-08
08806388287925Healing AbutmentAOHS60707AOHS60707T2023-06-08
08806388287932Healing AbutmentAOHS60802AOHS60802T2023-06-08
08806388287949Healing AbutmentAOHS60803AOHS60803T2023-06-08
08806388288359Healing AbutmentAOHS50654NAOHS50654NT2023-06-08
08806388288366Healing AbutmentAOHS50655NAOHS50655NT2023-06-08
08806388288373Healing AbutmentAOHS50657NAOHS50657NT2023-06-08
08806388288380Healing AbutmentAOHS50702NAOHS50702NT2023-06-08
08806388288397Healing AbutmentAOHS50703NAOHS50703NT2023-06-08
08806388288403Healing AbutmentAOHS50704NAOHS50704NT2023-06-08

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Primary DI, Brand, Company table
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07899995235312DRIVER HANDPIECE MINI ABUT. MEDIUMSin Sistema de Implante Nacional S/ANDP2026-07-14
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07899995235367DRIVER RATCHET ABUT. HEX 2MM MEDIUMSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235374DRIVER RATCHET ABUT. HEX 2MM SHORTSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235381DRIVER RATCHET ABUT. HEX 2MM EXT. SHORTSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235503DRIVER RATCHET RETRIVER M1.6MM LONGSin Sistema de Implante Nacional S/ANDP2026-07-14
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07899995235534DRIVER RATCHET RETRIVER M1.6MM LONGSin Sistema de Implante Nacional S/ANDP2026-07-14
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