FDA.reportPublic FDA data

Hand Driver for Cover Screw

Primary DI
07290112280886
Brand
Hand Driver for Cover Screw
Company
DENTACK IMPLANTS LTD
Model
HD09
Device description
Hand Driver for Cover Screw
Published
2019-03-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
07290112280886PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290112280886072901122808867290112280886

GMDN Terms#

Term, Definition table
TermDefinition
Dental torque wrenchA hand-held dental tool intended for the manual application of rotation to tighten/loosen/remove a device [e.g., dental implant, spatial register (localizer/tracker/calibrator)] fitted into or close to the oral cavity, and/or to a surgical instrument, in association with a dental surgical procedure [e.g., dental guided surgery registration]. It may have a built-in ratchet function, with forward and reverse direction, and a calibrated scale to which a recommended torque can be set; it is not a screwdriver. It is typically made of metallic or polymer materials and may have a standard socket connection to accommodate different tool bits/adaptors. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+97297660379info@pyramidion-is.com

Regulatory Flags#

DUNS number
514897185
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
07290112280824ET-1250ET-12502019-03-02
07290112280831Expansion tool-screw 6.35+wrench short - AssyET-18502019-03-02
07290112280848Expansion tool EX-screw 6.35+wrench long-AssyET-1250EX2019-03-02
07290112280855Expansion tool EX-screw+wrench short - AssyET-1850EX2019-03-02
07290112280862Long Driver 1.25DL-1252019-03-02
07290112280879Short Driver 1.25DS-1252019-03-02
07290112280893Insertion Tool Long 2.5ITL-2502019-03-02
07290112280909Insertion Tool Short 2.5ITS-2502019-03-02
07290112280916"Torque Ratchet Hex 1/4"" Wheel"RT-35002019-03-02
07290112280541Impression copingsIC-7502018-02-23
07290112280664Implant 4.1*5EDI-41052019-02-27
07290112280671Straight MU AbutmentMU-412N2019-02-27
07290112280688Multi Unit Abutment for EXMU-412EXN2019-02-26
07290112280695Straight MU AbutmentMU-413N2019-02-27
07290112280701Multi Unit Abutment for EXMU-413EXN2019-02-26
07290112280718Straight MU AbutmentMU-414N2019-02-27
07290112280725Multi Unit Abutment for EXMU-414EXN2019-02-26
07290112280732Angled MU abutment MU-17152019-02-27
07290112280749Angled MU abutment 17-1.5 for EXMU-1715EX2019-02-26
07290112280756Angled MU abutment MU-17302019-02-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08800313235913SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235920SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235937SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235944SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235951SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235968SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235975SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235982SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235999SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313236002SQ Guide Long DrillDENTIS CO. ,LTDNDP2026-07-09