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510(k) Data Aggregation
K Number
K142001Device Name
SYNTEC WETALI ORTHODONTIC MINI SCREWS
Manufacturer
SYNTEC SCIENTIFIC CORPORATION - TAIPEI OFFICE
Date Cleared
2015-03-18
(238 days)
Product Code
OAT
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
SYNTEC SCIENTIFIC CORPORATION - TAIPEI OFFICE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
THE SCREWS ARE INDICATED FOR USE AS A FIXED ANCHORAGE FOR ATTACHMENT OF ORTHODONTIC APPLIANCES TO FACILITATE THE ORTHODONTIC MOVEMENT OF TEETH. THEY ARE USED TEMPORARILY AND ARE REMOVED AFTER ORTHODONTIC TREATMENT HAS BEEN COMPLETED. THEY ARE INTENDED FOR SINGLE USE ONLY.
Device Description
The screws are manufactured from commercially SUS316L (stainless steel) and Ti6AL-4V (Titanium alloy). The screws are available with thread diameter are from 1.4mm to 2.0 mm, and total thread lengths from 6.0mm to 12.0mm. The minor technological modification for Syntec Wetali Orthodontic Mini Screws is re-designed self-drilling angle for more easily insertion and removal. The design of smooth curve surface of screw head is comfortable to patient and the screws with or without a 0.7mm diameter hole can supply different orthodontic methods for orthodontists.
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