Home GUDID D8964DTW200
American Dental Implant
Primary DI D8964DTW200
Brand American Dental Implant
Company AMERICAN DENTAL IMPLANT CORPORATION
Model 4DTW20
Catalog number 4DTW20
Device description 20 Newton Centimeter Torque Wrench (4mm Square Drive System)
Published 2018-07-31
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
OTC true
Product Codes# Code, Name table Code Name NDP Accessories, Implant, Dental, Endosseous
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NDP Accessories, Implant, Dental, Endosseous Dental 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status D8964DTW200 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Dental torque wrench A 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 835556429 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 DI Brand Model Catalog Published D8963250115SD0 American Dental Implant 3250115SD 3250115SD 2024-04-10 D896325010SD0 American Dental Implant 325010SD 325010SD 2024-04-10 D896325013SD0 American Dental Implant 325013SD 325013SD 2024-04-10 D896325015SD0 American Dental Implant 325015SD 325015SD 2024-04-10 D8964DTW300 American Dental Implant 4DTW30 4DTW30 2018-07-31 D8963ASAB0 American Dental Implant 3AS-AB 3AS-AB 2019-02-18 D8963ASB0 American Dental Implant 3AS-B 3AS-B 2019-02-18 D8963AS0 American Dental Implant 3AS 3AS 2018-07-31 D896AS0 American Dental Implant AS AS 2018-07-31 D896ASA0 American Dental Implant AS-A AS-A 2018-07-31 D896ASAG0 American Dental Implant AS-AG AS-AG 2018-07-31 D896ASAP0 American Dental Implant AS-AP AS-AP 2018-07-31 D896ASG0 American Dental Implant AS-G AS-G 2018-07-31 D896ASP0 American Dental Implant AS-P AS-P 2018-07-31 D896ASY0 American Dental Implant AS-Y AS-Y 2018-07-31 D896ADTD200 American Dental Implant ADTD20 ADTD20 2018-07-31 D896ADTD20S0 American Dental Implant ADTD20S ADTD20S 2018-07-31 D896ADTD230 American Dental Implant ADTD23 ADTD23 2018-07-31 D896ADTD23S0 American Dental Implant ADTD23S ADTD23S 2018-07-31 D896ADTD280 American Dental Implant ADTD28 ADTD28 2018-07-31
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