FDA.reportPublic FDA data

Tools

Primary DI
07290107274876
Brand
Tools
Company
A.B. DENTAL DEVICES LTD
Model
T8c-10-40
Catalog number
T8c-10-40
Device description
Ratchet-Torque Combination
Published
2019-10-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
17290107274873PackageGS110In Commercial Distribution
07290107274876PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729010727487317290107274873
07290107274876072901072748767290107274876

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 marker (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
+972732454900Info@ab-dent.com

Regulatory Flags#

DUNS number
534128491
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290107273008Prosthetic AccessoriesP24-bT_NP24-bT_N2026-08-25
07290107273329Prosthetic AccessoriesP25aP25a2026-08-25
07290107273336Prosthetic AccessoriesP25b-10P25b-102026-08-25
07290107277921Prosthetic AccessoriesP4LN-3.75,25P4LN-3.75,252026-08-25
07290107278607Prosthetic AccessoriesP64-3.75,17-4P64-3.75,17-42026-08-25
07290107278614Prosthetic AccessoriesP64-3.75,17-5P64-3.75,17-52026-08-25
07290107278638Prosthetic AccessoriesP64-3.75,30-4P64-3.75,30-42026-08-25
07290107278645Prosthetic AccessoriesP64-3.75,30-5P64-3.75,30-52026-08-25
07290111273292Prosthetic AccessoriesP4C-4,15P4C-4,152026-08-25
07290111273308Prosthetic AccessoriesP4C-4,25P4C-4,252026-08-25
07290111273346Prosthetic AccessoriesP4LC-4,15P4LC-4,152026-08-25
07290111273353Prosthetic AccessoriesP4LC-4,25P4LC-4,252026-08-25
07290111275043Prosthetic AccessoriesP14C-bTP14C-bT2026-08-25
07290111275050Prosthetic AccessoriesP14C-bT-ARP14C-bT-AR2026-08-25
07290111275067Prosthetic AccessoriesP14C-bTs-ARP14C-bTs-AR2026-08-25
07290111275074Prosthetic AccessoriesP14C-bTs-CP14C-bTs-C2026-08-25
07290111275364Prosthetic AccessoriesP55C-4,1P55C-4,12026-08-25
07290111275371Prosthetic AccessoriesP55C-4,2P55C-4,22026-08-25
07290111275388Prosthetic AccessoriesP55C-4,3P55C-4,32026-08-25
07290111275395Prosthetic AccessoriesP55C-4,4P55C-4,42026-08-25

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Primary DI, Brand, Company table
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08809918259720LW OSS Abutment Lab AnalogOssvis Co., Ltd.NDP2026-10-13
03700977513110SlimEUROTEKNIKANDP2026-10-12
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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