FDA.reportPublic FDA data

Avinent torque wrench kit

Primary DI
05712821001351
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 prosth
Published
2019-03-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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 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

Regulatory Flags#

DUNS number
306155953
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05712821017758Elos Accurate Pre-Milled BlankPMB-NGM45-1PMB-NGM45-12026-03-06
05712821017369Elos Accurate Pre-Milled BlankPMB-NBR35-1PMB-NBR35-12023-06-19
05712821017376Elos Accurate Pre-Milled BlankPMB-NBR43-1PMB-NBR43-12023-06-19
05712821017383Elos Accurate Pre-Milled BlankPMB-SBO33-1PMB-SBO33-12023-06-19
05712821017390Elos Accurate Pre-Milled BlankPMB-SBO41-1PMB-SBO41-12023-06-19
05712821017406Elos Accurate Pre-Milled BlankPMB-ATE36-1PMB-ATE36-12023-06-19
05712821017413Elos Accurate Pre-Milled BlankPMB-ATE42-1PMB-ATE42-12023-06-19
05712821017420Elos Accurate Pre-Milled BlankPMB-NBR50-1PMB-NBR50-12024-01-04
05712821017437Elos Accurate Pre-Milled BlankPMB-NBR60-1PMB-NBR60-12024-01-04
05712821017444Elos Accurate Pre-Milled BlankPMB-NBA30-1PMB-NBA30-12024-01-04
05712821017451Elos Accurate Pre-Milled BlankPMB-NBA35-1PMB-NBA35-12024-01-16
05712821017468Elos Accurate Pre-Milled BlankPMB-NBA43-1PMB-NBA43-12024-01-16
05712821017475Elos Accurate Pre-Milled BlankPMB-NBA60-1PMB-NBA60-12024-01-04
05712821017482Elos Accurate Pre-Milled BlankPMB-BRA41-1PMB-BRA41-12024-01-04
05712821017499Elos Accurate Pre-Milled BlankPMB-BRA35-1PMB-BRA35-12024-01-04
05712821017505Elos Accurate Pre-Milled BlankPMB-BRA51-1PMB-BRA51-12024-01-04
05712821017512Elos Accurate Pre-Milled BlankPMB-ATO35-1PMB-ATO35-12024-01-04
05712821017529Elos Accurate Pre-Milled BlankPMB-ATO45-1PMB-ATO45-12024-01-04
05712821017536Elos Accurate Pre-Milled BlankPMB-ATE48-1PMB-ATE48-12024-01-04
05712821017543Elos Accurate Pre-Milled BlankPMB-ATE54-1PMB-ATE54-12024-01-04

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842092187722PreatPreat CorporationNDP2026-06-08
08056591028154JDentalCare Dental InstrumentsJ DENTAL CARE SRLNDP2026-06-08
00840481133756LOCATORZest Anchors, LLCNDP2026-06-05
07630031778086NAInstitut Straumann AGNDP2026-06-03
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