FDA.report

Ditron Dental

Primary DI
07290109284385
Brand
Ditron Dental
Company
DITRON DENTAL LTD
Model
TWS-200400
Catalog number
TWS-200400
Device description
Torque Ratchet Wrench sqr 4.0, 10-70 Ncm
Published
2024-03-27
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

Related Records

Contact Domains

Product Codes

CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07290109284385PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07290109284385072901092843857290109284385

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+97286711884info@ditrondental.com

Regulatory Flags

DUNS number
531878633
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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07290109287393Ditron DentalTTI-C3501-45TTI-C3501-452025-04-09
07290109287409Ditron DentalTTI-C4500-08TTI-C4500-082025-04-09
07290109287416Ditron DentalTTI-C4500-15TTI-C4500-152025-04-09
07290109287423Ditron DentalTTI-C4500-25TTI-C4500-252025-04-09
07290109287430Ditron DentalTTI-C4500-35TTI-C4500-352025-04-09
07290109287447Ditron DentalTTI-C4501-08TTI-C4501-082025-04-09
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