FDA.reportPublic FDA data

CERALOG® Torque wrench

Primary DI
E219H532010301
Brand
CERALOG® Torque wrench
Company
ALTATEC GmbH
Model
H5320.1030
Catalog number
H5320.1030
Device description
CERALOG® Torque wrench, length 83 mm, 15-35 Ncm
Published
2024-01-19
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
E219H53201030300Direct MarkingHIBCC0
E219H532010301PrimaryHIBCC0

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
9999999999info@camlog.com

Regulatory Flags#

DUNS number
322018193
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

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E219J508133131Guide dense bone drill 2, PLJ5081.3313J5081.33132025-05-13
E219J508133161Guide dense bone drill 2, PLJ5081.3316J5081.33162025-05-13
E219J508138071Guide dense bone drill 2, PLJ5081.3807J5081.38072025-05-13
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E219J508138111Guide dense bone drill 2, PLJ5081.3811J5081.38112025-05-13
E219J508138131Guide dense bone drill 2, PLJ5081.3813J5081.38132025-05-13
E219J508138161Guide dense bone drill 2, PLJ5081.3816J5081.38162025-05-13
E219J508143071Guide dense bone drill 2, PLJ5081.4307J5081.43072025-05-13
E219J508143091Guide dense bone drill 2, PLJ5081.4309J5081.43092025-05-13
E219J508143111Guide dense bone drill 2, PLJ5081.4311J5081.43112025-05-13
E219J508143131Guide dense bone drill 2, PLJ5081.4313J5081.43132025-05-13
E219J508143161Guide dense bone drill 2, PLJ5081.4316J5081.43162025-05-13
E219J508150071Guide dense bone drill 2, PLJ5081.5007J5081.50072025-05-13

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