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510(k) Data Aggregation
K Number
K182145Device Name
tün® ultrasonic tips product family
Manufacturer
Engineered Endodontics
Date Cleared
2019-06-07
(303 days)
Product Code
ELC
Regulation Number
872.4850Why did this record match?
Applicant Name (Manufacturer) :
Engineered Endodontics
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
tün® ultrasonic tips are intended for use by dental professionals for the removal of soft and hard tissue during endodontic root canal preparation procedures. They can also aid in the removal of endodontic posts and other intra-canal blockages.
Device Description
tün® ultrasonic tips are an accessory to a piezoelectric ultrasonic handpiece and scaler unit. The tün® ultrasonic tips are made from 17-4ph Stainless Steel. Alloy 17-4ph (UNS S17400), Type 630, is a chromium-nickel-copper precipitation-hardening martensitic stainless steel with an addition of niobium. The tips will be available in M3xO.5 and M3x0.6 thread with 6 different tip designs. 1 tip design is devised for post removal; the remaining 5 tips are designed for negotiating the various angles and directions of root canals. Certain models have diamond (zirconium nitride) coating.
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