FDA.reportPublic FDA data

Avinent torque wrench kit

Primary DI
05712821001801
Brand
Avinent torque wrench kit
Company
Elos Medtech Pinol A/S
Model
C8120
Catalog number
N/A
Device description
A dental torque wrench for placement and adjustment of dental implants, abutments, abutment screw and prosthetic screws during oral surgery and prosthetic procedures.
Published
2019-03-19
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
05712821001351Direct MarkingGS10
05712821001801PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05712821001351057128210013515712821001351
05712821001801057128210018015712821001801

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

Regulatory Flags#

DUNS number
306155953
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
05712821014696Elos Accurate Hybrid Base G EngagingHBE-ATE30-G1.0HBE-ATE30-G1.02026-10-06
05712821014702Elos Accurate Hybrid Base G EngagingHBE-ATE30-G2.0HBE-ATE30-G2.02026-10-06
05712821014719Elos Accurate Hybrid Base G EngagingHBE-ATE30-G3.0HBE-ATE30-G3.02026-10-06
05712821014726Elos Accurate Hybrid Base G EngagingHBE-ATE30-G4.0HBE-ATE30-G4.02026-10-06
05712821014733Elos Accurate Hybrid Base G EngagingHBE-ATE36-G1.0HBE-ATE36-G1.02026-10-06
05712821014740Elos Accurate Hybrid Base G EngagingHBE-ATE36-G2.0HBE-ATE36-G2.02026-10-06
05712821014757Elos Accurate Hybrid Base G EngagingHBE-ATE36-G3.0HBE-ATE36-G3.02026-10-06
05712821014764Elos Accurate Hybrid Base G EngagingHBE-ATE36-G4.0HBE-ATE36-G4.02026-10-06
05712821014771Elos Accurate Hybrid Base G EngagingHBE-ATE42-G1.0HBE-ATE42-G1.02026-10-06
05712821014788Elos Accurate Hybrid Base G EngagingHBE-ATE42-G2.0HBE-ATE42-G2.02026-10-06
05712821014795Elos Accurate Hybrid Base G EngagingHBE-ATE42-G3.0HBE-ATE42-G3.02026-10-06
05712821014801Elos Accurate Hybrid Base G EngagingHBE-ATE42-G4.0HBE-ATE42-G4.02026-10-06
05712821014818Elos Accurate Hybrid Base G EngagingHBE-ATE48-G1.0HBE-ATE48-G1.02026-10-06
05712821014825Elos Accurate Hybrid Base G EngagingHBE-ATE48-G2.0HBE-ATE48-G2.02026-10-06
05712821014832Elos Accurate Hybrid Base G EngagingHBE-ATE48-G3.0HBE-ATE48-G3.02026-10-06
05712821014849Elos Accurate Hybrid Base G EngagingHBE-ATE48-G4.0HBE-ATE48-G4.02026-10-06
05712821014856Elos Accurate Hybrid Base G EngagingHBE-ATE54-G1.0HBE-ATE54-G1.02026-10-06
05712821014863Elos Accurate Hybrid Base G EngagingHBE-ATE54-G2.0HBE-ATE54-G2.02026-10-06
05712821014870Elos Accurate Hybrid Base G EngagingHBE-ATE54-G3.0HBE-ATE54-G3.02026-10-06
05712821014887Elos Accurate Hybrid Base G EngagingHBE-ATE54-G4.0HBE-ATE54-G4.02026-10-06

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Primary DI, Brand, Company table
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08809918259720LW OSS Abutment Lab AnalogOssvis Co., Ltd.NDP2026-10-13
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03700977513639iFlag ReversoEUROTEKNIKANDP2026-10-12
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06942799001100SHINING 3D®Shining 3D Tech Co., Ltd.NDP2026-10-09
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