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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.

AI/ML Overview

This document describes the tün® ultrasonic tips product family and compares it to a predicate device (EDS Ultrasonic Tips, K132609) to establish substantial equivalence for FDA 510(k) clearance.

Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present "acceptance criteria" in the typical sense of a target performance metric for a specific study. Instead, it aims to demonstrate substantial equivalence to a legally marketed predicate device through a direct comparison of various characteristics. The "reported device performance" is implicitly established by showing that the proposed device's characteristics are identical or sufficiently similar to the predicate, with any differences deemed not to raise new questions of safety or effectiveness.

Here's a summary of the comparison, which serves as the basis for performance acceptance:

Item	Acceptance Criteria (based on Predicate Device EDS Ultrasonic Tips K132609)	Reported Device Performance (Proposed Device tün® ultrasonic tips)	Comments on Equivalence
General Information / Uses & Indications
FDA Product Code	ELC	ELC	Identical. Substantially Equivalent.
FDA Regulation Number	872.4950	872.4950	Identical. Substantially Equivalent.
FDA Regulation Class	Class II	Class II	Identical. Substantially Equivalent.
FDA Regulation Description	Scaler, Ultrasonic	Scaler, Ultrasonic	Identical. Substantially Equivalent.
Intended Use / Indication for Use	"EDS 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."	"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."	Except for branding, statements are identical. Branding does not raise new safety/effectiveness questions. Substantially Equivalent.
FDA Device Description	Stainless steel, M3x0.5 and #5-40 thread, 6 different tip designs.	Stainless steel, M3x0.5 and M3x0.6 thread, 6 different tip designs.	Except for branding and thread standards (M3x0.6 vs #5-40), descriptions are identical. Citing different but equivalent standards for thread sizes does not raise new safety/effectiveness questions. Substantially Equivalent.
Intended User(s)	Assumed Dentists, Endodontists, Oral surgeons, and Dental hygienists	Dentists, Endodontists, Oral surgeons, and Dental hygienists	Assumed identical to predicate. Substantially Equivalent.
Intended Use Environment	Assumed dental clinics	In dental clinics	Assumed identical to predicate. Substantially Equivalent.
Contra-Indications	"There are no known contra-indications when used as recommended."	"There are no known contra-indications when used as recommended."	Identical. Substantially Equivalent.
Warnings	Identical to proposed device warnings.	"Please refer to the instructions for use of the manufacturer of the piezoelectric ultrasonic unit. It is important to note that the different..." (text cutoff)	Identical. Substantially Equivalent.
Precautions	Identical to proposed device precautions.	"• Do not start the piezoelectric ultrasonic generator with damaged ultrasonic tips. • For best results, and your safety, the use of a visual aid is recommended. • Do not heat above 275°F/135°C. • Tips that have been distorted in any fashion should be discarded. • To avoid overheating the dentin structures, do not apply continuous contact for more than 30 seconds. • The tip must be tightened onto the ultrasonic handpiece prior to use. Please pay attention not to over tighten nor under tighten."	Identical. Substantially Equivalent.
Sterilization Issues
Sterilization Status	Provided non-sterile.	Provided non-sterile.	Identical. Substantially Equivalent.
Sterilization Instructions	Identical to proposed device instructions, except for branding.	Identical to predicate instructions, except for branding.	Except for branding, instructions are identical. Branding does not raise new safety/effectiveness questions. Substantially Equivalent.
Sterilization Parameters	Gravity Steam Sterilizer: 250°F/121°C, 30 min cycle, 30 min max dry. Prev. Steam Sterilizer: 270°F/132°C, 4 min cycle, 30 min max dry.	Gravity Steam Sterilizer: 250°F/121°C, 30 min cycle, 30 min max dry. Prev. Steam Sterilizer: 270°F/132°C, 4 min cycle, 30 min max dry.	Identical. Substantially Equivalent.
Operating Principles & Materials
Operating Principle	Used with piezoelectric ultrasonic handpiece and scaler. Vibrate at high frequencies (up to 40,000 Hz).	Interacts with piezo ultrasonic hand piece and unit. Used on units operating in 20,000hz – 35,000hz range.	Identical operating principles with similar operational ranges. Substantially Equivalent.
Comparison of Tip Shapes	6 variants, various shapes (e.g., Short, Robust, Radiused, Pointed).	6 variants, various shapes (e.g., Radiused, Ball, Football, Disc-Shaped, Short, Robust).	Both offer common tip shapes for the industry. Differences in shape do not introduce new safety/effectiveness questions. Substantially Equivalent.
Construction Materials	316 Stainless Steel (Chromium, Nickel, Molybdenum austenitic stainless steel).	17-4ph Stainless Steel (Chromium, Nickel, Copper precipitation-hardening martensitic stainless steel).	Difference in materials reflects manufacturing methods (sintering vs. machining) and does not affect overall safety/performance. Substantially Equivalent.
Coatings	None (Note: EDS's prior device K960889 used Titanium Nitride/Zirconium Nitride)	Nickel Plating or Diamond Nickel Plating.	Proposed device is plated, predicate is not (but a prior predicate did have plating). This difference is a function of manufacturing method and does not affect overall safety/performance. Substantially Equivalent.
Clinical Use / Interactions with Other Devices
Interaction with other products	Accessory to piezoelectric ultrasonic handpiece and scaler unit with M3x0.5 or #5-40 threads. Used with third-party ultrasonic scalers.	Designed to function on most brands of Piezo-Electric type dental ultrasonic Scalers that use an M3x0.5 or M3x0.6 thread.	Both require third-party ultrasonic scalers using one of two thread types. Functionally, devices are the same. Substantially Equivalent.
Packaging Specifications / Configurations
Catalog Numbering	Formulaic system for 12 variants (610-XX or 615-XX).	Formulaic system for 12 variants (tun-e-X or tun-e-Xe).	Systems are different, but both encode for 12 variants. No new issues of safety or effectiveness. Substantially Equivalent.
Packaging Configurations	Sold as individual tips.	Sold as individual tips.	Identical. Substantially Equivalent.
Packaging Materials	Plastic pouch.	Plastic tray.	No specific comment on equivalence provided for this difference, though typically minor differences in inert packaging materials are acceptable if they maintain sterility and protection. This would likely be assessed under recognized standards for packaging.
Dimensional Specifications
Dimensions	Approximately 15 mm long by 20 mm wide.	Approximately 12 mm long by 14 mm wide.	Minor variations do not introduce new safety/effectiveness questions. Substantially Equivalent.
Weight	Approximately 1.2 grams.	Approximately 0.75 grams.	Minor variations do not introduce new safety/effectiveness questions. Substantially Equivalent.
Environment Specifications
Operating Environment	Not Known/Indicated.	Room Temperature.	Proposed device's operating environment does not raise new safety/effectiveness questions. Substantially Equivalent.
Storage Environment	Not indicated.	Room Temperature.	Proposed device's storage environment does not raise new safety/effectiveness questions. Substantially Equivalent.
Applied Standards	Not indicated/known/cited.	ISO 7405 (biocompatibility), ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization), ISTA 3A (packaging/shipping).	Compliance with recognized consensus standards (even if predicate didn't explicitly cite them) bolsters argument for safety and effectiveness. Substantially Equivalent.

Sample size used for the test set and the data provenance
This document describes a 510(k) submission that relies on demonstrating substantial equivalence to a predicate device, rather than presenting a performance study with a specific test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective). The "test" is essentially a comparison table (as presented above) where the proposed device's characteristics are matched against the predicate's known characteristics. There is no independent "test set" of patient data or device performance data in the context of clinical trials described here. Instead, compliance with recognized consensus standards for biocompatibility (ISO 7405, ISO 10993-5, ISO 10993-10) and packaging (ISTA 3A) replaces the need for a de novo clinical test set derived from patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable (N/A). As this is a substantial equivalence submission based on comparative analysis of device characteristics and compliance with standards, there is no "test set" requiring expert ground truth establishment in a clinical sense. The "ground truth" for the comparison is the publicly available information and specifications of the predicate device and the recognized consensus standards.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A. There is no test set in the clinical evaluation sense that would require an adjudication method. The determination of substantial equivalence is made by the FDA reviewer based on the provided comparative analysis.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
N/A. This device is an ultrasonic tip (a mechanical accessory) for dental procedures, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies or AI assistance effect sizes are not relevant to this submission.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
N/A. This is a physical, mechanical device, not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this submission is based on:
- Specifications and characteristics of the legally marketed predicate device (EDS Ultrasonic Tips, K132609). These are established by its prior FDA clearance and public documentation.
- Recognized consensus standards: ISO 7405, ISO 10993-5, ISO 10993-10 for biocompatibility, and ISTA 3A for packaging/shipping performance. Compliance with these standards is considered evidence of acceptable safety and performance.
The sample size for the training set
N/A. As this is a mechanical device and not an AI/machine learning product, there is no "training set."
How the ground truth for the training set was established
N/A. There is no training set for this device.

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