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.

Summary

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June 7, 2019

Engineered Endodontics % John Ziobro Principal Consultant SpectraMedEx, LLC 3215 Golf Road #1459 Delafield, Wisconsin 53018

Re: K182145

Trade/Device Name: tün® ultrasonic tips product family Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: Class II Product Code: ELC Dated: April 24, 2019 Received: May 1, 2019

Dear John Ziobro:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for Malvina B Eydelman, M.D. Director OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K182145

Device Name tün® ultrasonic tips product family

Indications for Use (Describe)

tim® ultrasonic tips are intended for use by dental professionals for the removal of soft and hard tissue during endodonic root canal preparation procedures. They can also aid in the removal of endodontic posts and other intra-canal blockages.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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tün® ultrasonic tips Product Family TRADIONAL 510(K) SUMMARY

Section 3

K182145 Traditional 510(k) Summarv

1. Summary Date: June 1, 2018
Applicant Name: Engineered Endodontics, LLC 2. W134 N4965 Campbell Drive Menomonee Falls, WI 53051 Establishment Registration Number: 3012322979
1. Submission Correspondent: On behalf of Engineered Endodontics, the following consultant is assigned the responsibility of submission correspondence:

John F. Ziobro, Principal Consultant SpectraMedEx, LLC 3215 Golf Road, #149 Delafield, WI 53018 Ph: 262.719.8922

1. Trade Name: tün® ultrasonic tips product family
న. Common Name: Scaler, Ultrasonic
1. Description:

1. Manufacturing Site: Engineered Endodontics, LLC W134 N4965 Campbell Drive Menomonee Falls, WI 53051 Establishment Registration Number: 3012322979
1. Classification Regulation, Class, Product Code, Description & Panel:

Regulation #	Class	ProCode	Description	Panel
21CFR872.4850	II	ELC	Scaler, Ultrasonic	Dental

Predicate Device(s): Predicate: 9.

510(k) Number: K132609 ESSENTIAL DENTAL SYSTEMS, INC. Manufacturer: 89 Leuning Street, Suite 8 South Hackensack, NJ 07606 Trade Name: EDS ULTRASONIC TIPS Classification Regulation, Class, Product Code, Description & Panel:

Regulation #	Class	ProCode	Description	Panel
21CFR872.4850	II	ELC	Scaler, Ultrasonic	Dental

tün® ultrasonic tips Product Family Traditional 510(k) Submission

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1. Proposed Indication for 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.
1. Compliance to Special Controls / Performance Standards: Compliance to the following recognized consensus standards is declared:
- ISO 7405 Second edition 2008-12-15 Dentistry Evaluation of biocompatibility of medical devices used in dentistry [Including: Amendment 1 (2013)]. The application of this standard resulting in testing to:
  - ISO 10993-5:2009 / (R) 2014 Biological Evaluation of Medical Devices-Part 5: Tests for in vitro cytotoxicity
  - ISO 10993-10:2009 / (R) 2014 Biological Evaluation of Medical Devices-Part 10: Tests for irritation and skin sensitization
- ISTA 3A General Simulation Performance Test Procedure: Packaged- Products for Parcel Delivery System Shipment 150lbs or less
1. Technological Characteristics

The proposed device is similar to the predicate device and as substantially equivalent technological characteristics.

1. Comparison to Predicates
  The main differences between the tün® ultrasonic tips under review and the predicate device cleared under K132609 are as follows:
The proposed device is plated while the predicate device is not. This difference is a function of the manufacturing method and does not affect the overall safety or performance of the device. Note: The predicate device chosen by EDS that cleared under K960889 used Titanium Nitride as plating materials.
The proposed device is manufactured by sintering while the predicate device is machined. The end result ● from either method are ultrasonic tips with similar geometries and identical intended uses. The different manufacturing methods simply reflect the in-house equipment / manufacturing capabilities of the two different companies and do not affect the overall safety or performance of the device.
. The proposed device uses a Chromium:Nickel:Copper stainless steel alloy, while the predicate device uses a Chromium:Nickel:Molybdenum stainless steel. The materials were chosen based on the manufacturing methods and do not affect the overall safety or performance of the device.
The proposed device offers 6 variants; the predicate device offers 6 variants, but there isn't an exact 1:1 matchup and the overall sizes and weights are slightly different. However, these differences do not raise any new questions of safety or effectiveness.

The minor differences between the ultrasonic tips under review and the predicate device cleared under K132609 are as follows:

The proposed device consistently references the ISO standard for thread sizes to interface with the ultrasonic ● generators (M3x0.5 or M3x0.6 thread), while the predicate device references one ISO and one American standard (M3x0.5 and #5-40 thread).
The proposed device explicitly states the intended users, the intended use environment, the targeted patient . population, the operating & storage temperatures, compliance to specific standards, etc. while the predicate device does not.

The proposed device states that they are to be "used on piezo ultrasonic endodontic and scaler units which operate in the range of 20,000hz - 35,000hz," while the predicate device states that they vibrate "at high frequencies (up to 40,000 Hz)."

A table showing substantial equivalence to the predicate device follows:

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Image /page/5/Picture/0 description: The image shows the words "engineered endodontics" in green font. The word "engineered" is on the top line, and the word "endodontics" is on the bottom line. The words are in a sans-serif font and are outlined in a light gray color. There is a registered trademark symbol to the right of the word "endodontics".

tün® ultrasonic tips Product Family TRADIONAL 510(K) SUMMARY

Volume 2

Section 3

	Proposed Device: tün® ultrasonic tipsProduct Family	Predicate Device: EDS Ultrasonic TipsK132609
Item			Comments
COMPARISON OF GENERAL INFORMATION / USES & INDICATIONS
Photograph	Image: tün® ultrasonic tips	Image: EDS Ultrasonic Tips	For Information Purposes only, but the images showthat the Proposed Device is Substantially Equivalentin its overall shape/configurations to the predicatedevice.
FDA Product Code	ELC	ELC	Identical to the predicate.Therefore, Substantially Equivalent
FDA Regulation Number	872.4950	872.4950	Identical to the predicate.Therefore, Substantially Equivalent
FDA Regulation Class	Class II	Class II	Identical to the predicate.Therefore, Substantially Equivalent
FDA RegulationDescription	Scaler, Ultrasonic	Scaler, Ultrasonic	Identical to the predicate.Therefore, Substantially Equivalent
Intended Use /Indication for Use(As statement appears in the510(k) indications for useform)	tün® ultrasonic tips are intended for use by dentalprofessionals for the removal of soft and hard tissueduring endodontic root canal preparation procedures.They can also aid in the removal of endodontic posts andother intra-canal blockages.	EDS Ultrasonic Tips are intended for use by dentalprofessionals for the removal of soft and hard tissue duringendodontic root canal preparation procedures. They canalso aid in the removal of endodontic posts and other intra-canal blockages.	Except for branding issues (tün® versus EDS), theIndication for Use statements are identical. Brandingdoes not raise any new questions of safety ofeffectiveness.Therefore, Substantially Equivalent
FDA Device Description(As it appears in theapplicable FDA SummaryStatement)	tün® ultrasonic tips are an accessory to a piezoelectricultrasonic handpiece and scaler unit. These poweredcomponents are not included as part of the devicesubmitted for application with the 510(k) submission.tün® ultrasonic tips are stainless steel and will beavailable in M3x0.5 and M3x0.6 thread with 6 differenttip designs. 1 tip design is devised for post removal; theremaining 5 tips are designed for negotiating the variousangles and directions of root canals.	EDS Ultrasonic Tips are an accessory to a piezoelectricultrasonic handpiece and scaler unit. These poweredcomponents are not included as part of the devicesubmitted for application with the 510(k) submission. EDSUltrasonic Tips are stainless steel and will be available inM3x0.5 and #5-40 thread with 6 different tip designs. 1 tipdesign is devised for post removal; the remaining 5 tips aredesigned for negotiating the various angles and directionsof root canals.	Except for branding issues (tün® versus EDS), andthe use of thread standards (M3x0.6 vs #5-40), theDevice Descriptions are identical. The proposeddevice consistently references the ISO standard forthread sizes, while the predicate device references oneISO and one American standard). Branding issues andciting different but equivalent standards for threadsizes do not raise any new questions of safety ofeffectiveness.Therefore, Substantially Equivalent
Intended User(s)	Dentists, Endodontists, Oral surgeons, and Dentalhygienists	Although not formally stated, assumed to be Dentists,Endodontists, Oral surgeons, and Dental hygienists	Although not known to be formally stated in thepredicate's submission, the intended users areassumed to be identical to the predicate.
	Proposed Device: tün® ultrasonic tipsProduct Family	Predicate Device: EDS Ultrasonic TipsK132609
Item			Comments
Intended UseEnvironment	In dental clinics	Although not formally stated, assumed to be dental clinics	Therefore, Substantially EquivalentAlthough not known to be formally stated in thepredicate's submission, the Intended Use Environmentis assumed to be identical to the predicate.Therefore, Substantially Equivalent
Contra-Indication(s)	There are no known contra-indications when used asrecommended.	There are no known contra-indications when used asrecommended.	Identical to the predicate.Therefore, Substantially Equivalent
Warnings	Please refer to the instructions for use of the manufacturer ofthe piezoelectric ultrasonic unit. It is important to note thatthe different	Please refer to the instructions for use of the manufacturer ofthe piezoelectric ultrasonic unit. It is important to note that thedifferent	Identical to the predicate.Therefore, Substantially Equivalent
Precautions	• Do not start the piezoelectric ultrasonic generator withdamaged ultrasonic tips.• For best results, and your safety, the use of a visualaid is recommended.• Do not heat above 275°F/135°C.• Tips that have been distorted in any fashion should bediscarded.• To avoid overheating the dentin structures, do notapply continuous contact for more than 30 seconds.• The tip must be tightened onto the ultrasonic handpieceprior to use. Please pay attention not to over tighten norunder tighten.	• Do not start the piezoelectric ultrasonic generator withdamaged ultrasonic tips.• For best results, and your safety, the use of a visual aid isrecommended.• Do not heat above 275°F/135°C.• Tips that have been distorted in any fashion should bediscarded.• To avoid overheating the dentin structures, do not applycontinuous contact for more than 30 seconds.• The tip must be tightened onto the ultrasonic handpieceprior to use. Please pay attention not to over tighten norunder tighten.	Identical to the predicate.Therefore, Substantially Equivalent
		COMPARISON OF STERILIZATION ISSUES
Sterilization Status	Provided non-sterile.	Provided non-sterile.	Identical Sterilization Status.Therefore, Substantially Equivalent
Sterilization Instructions	tün ultrasonic tips are not sold sterile and must becleaned and sterilized prior to each use.A. Wipe tips with a cleaning disinfectant.B. Cleaning -Pre-clean using a high-quality, pH neutral, ultrasoniccleaning solution. Follow solution manufacturer'sinstructions.Dry thoroughly with a towel and compressed air.C. Steam Sterilization -Place the tips to be sterilized in an autoclave pouchprior to sterilization.	EDS Ultrasonic Tips are not sold sterile and must becleaned and sterilized prior to each use.A. Wipe tips with a cleaning disinfectant.B. Cleaning -Pre-clean using a high-quality, pH neutral, ultrasoniccleaning solution. Follow solution manufacturer'sinstructions.Dry thoroughly with a towel and compressed air.C. Steam Sterilization -Place the tips to be sterilized in an autoclave pouchprior to sterilization.	Except for branding issues (tün® versus EDS), theSterilization Instructions are identical. Branding doesnot raise any new questions of safety of effectiveness.Therefore, Substantially Equivalent
Sterilization Parameters	Gravity Steam Sterilizer:• Temperature: 250° F/121° C.• Cycle Time: 30 minutes• Maximum Dry Time: 30 minutesPrevacuum Steam Sterilizer:	Gravity Steam Sterilizer:• Temperature: 250° F/121° C.• Cycle Time: 30 minutes• Maximum Dry Time: 30 minutesPrevacuum Steam Sterilizer:	Identical Sterilization Parameters.Therefore, Substantially Equivalent

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tün® ultrasonic tips

Volume 2

Section 3

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Image /page/7/Picture/0 description: The image contains the words "engineered endodontics" in a stylized font. The words are stacked on top of each other, with "engineered" on the top line and "endodontics" on the bottom line. The text is green with a light gray outline. There is a registered trademark symbol next to the word "endodontics".

tün® ultrasonic tips

Volume 2

Section 3

	Proposed Device: tün® ultrasonic tipsProduct Family			Predicate Device: EDS Ultrasonic TipsK132609		Comments
Item	• Temperature: 270° F/132° C.			• Temperature: 270° F/132° C.
	• Cycle Time: 4 minutes			• Cycle Time: 4 minutes
	• Maximum Dry Time: 30 minutes			• Maximum Dry Time: 30 minutes

Operating Principle	tün tips interact with piezo ultrasonic hand piece andunit. tün tips are an accessory to a piezo ultrasonic handpiece and unit.tün tips are used on piezo ultrasonic endodontic andscaler units which operate in the range of 20,000hz –35,000hz.		COMPARISON OF OPERATING PRINCIPLES & MATERIALSUsed in conjunction with piezoelectric ultrasonic handpieceand scaler. Ultrasonic energy vibrates tip at highfrequencies (up to 40,000 Hz)			Identical Operating Principles with similar operationalranges.Therefore, Substantially Equivalent
Comparison of Tip Shapes	TipShapeE1 Radiused Tip with diamondE2 Radiused Tip without diamondE3 Ball TipE4 Football TipE5 Disc-Shaped TipE6 Short, Robust Tip	EDS TipEDS 2/3EDS 2/3EDS 4EDS 4EDS 5EDS 1	TipEDS 1EDS 2EDS 3EDS 4EDS 5EDS 6Equivalent	ShapeShort, Robust TipRadiused TipRadiused Tip IILarge Point TipSmall Pointed TipN/A - Irrigation Tip	tün TipE6E1/2E1/2E3/4/5E1/2No Direct	Both the predicate device and the proposed deviceoffer the various tip shapes that are commonly used inthe industry. The differences in tip shape do notintroduce any new questions of safety oreffectiveness.Therefore, Substantially Equivalent
Construction Materials	17-4ph Stainless SteelAlloy 17-4PH (UNS S17400), Type 630, is a chromium-nickel-copper precipitation-hardening martensiticstainless steel with an addition of niobium. 17-4PHcombines high strength and hardness with goodcorrosion resistance.		316 Stainless SteelAlloy 316/316L (UNS S31600/ S31603) is a chromium-nickel- molybdenum austenitic stainless steel developed toprovide improved corrosion resistance to Alloy 304/304Lin moderately corrosive environments. It is often utilized inprocess streams containing chlorides or halides. Theaddition of molybdenum improves general corrosion andchloride pitting resistance. It also provides higher creep,stress-to-rupture and tensile strength at elevatedtemperatures.			The proposed device uses a Chromium:Nickel:Copper stainless steel alloy, while the predicate deviceuses a Chromium:Nickel:Molybdenum stainless steelalloy. The difference in materials reflect differentmanufacturing methods (sintering versus machining)and does not affect the overall safety or performanceof the finished device.Therefore, Substantially Equivalent
Coatings	Nickel Plating orDiamond Nickel Plating		None			The proposed device is plated while the predicatedevice is not. This difference is a functionmanufacturing method and does not affect the overallsafety or performance of the device. Note: Thepredicate device chosen by K132609 usedTitanium Nitride and Zirconium Nitride as platingmaterials - see K960889.Therefore, Substantially Equivalent
				COMPARISON OF CLINICAL USE / INTERACTIONS WITH OTHER DEVICES
Interaction with otherproducts and/or itemsused with the product	tün instruments have been designed to function on mostbrands of Piezo-Electric type dental ultrasonic Scalersthat use an M3x0.5 or M3x0.6 thread. Refer to your			EDS Ultrasonic Tips are an accessory to a piezoelectricultrasonic handpiece and scaler unit with M3x0.5 or #5-40threads		Both devices require the use of third-party ultrasonicscalers. These devices use one of two thread typeseither M3x0.5 or M3x0.6/#5-40. Functionally, the

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Image /page/8/Picture/0 description: The image shows the words "engineered endodontics" stacked on top of each other. The words are in a green sans-serif font with a light gray outline. The word "engineered" is on top, and the word "endodontics" is below it. There is a registered trademark symbol to the right of the word "endodontics".

tün® ultrasonic tips Product Family TRADIONAL 510(K) SUMMARY

Volume 2

Section 3

Item	Proposed Device: tün® ultrasonic tipsProduct Family	Predicate Device: EDS Ultrasonic TipsK132609	Comments
	ultrasonic machine owner's manual for further details onthe use of these types of devices.		devices are same.Therefore, Substantially Equivalent
COMPARISON OF PACKAGING SPECIFICATIONS / CONFIGURATIONS
Catalog Numbering	The catalog number schema uniquely identifies eachvariant as tun-e-X or tun-e-XeWhere e-X = Satelec type threads and X = the tip stylefrom 1 to 6And e-Xe = EMS type threads and X = the tip style from1 to 6.	The catalog number schema uniquely identifies eachvariant as 610-XX or 615-XXWhere 610 = E type threads; 615 = M type threadsAnd XX = the tip style from 01 to 06.Image: 610-xx E-Threads Fit These Units:Image: 615-xx M-Threads Fit These Units:	Both the proposed and predicate devices offer a totalseries of 6 tips that use two different thread styles fora total of 12 different tips. The proposed devices callM3x0.6 threads "Satelec" style, while the predicatecalls them "E" style and proposed devices callsM3x0.5 threads "E" style, while the predicate callsthem "M" style. Both devices use a formulaic catalognumbering system to encode for the 12 variants.Although the systems are different, no new issues ofsafety or effectiveness are introduced.Therefore, Substantially Equivalent
Packaging Configurations	Sold as individual tips	Sold as individual tips	Identical to the predicate.Therefore, Substantially Equivalent
Packaging Materials	Plastic tray	Plastic pouch	Identical to the predicate.Therefore, Substantially Equivalent
COMPARISON OF DIMENSIONAL SPECIFICATIONS
Dimensions	Each tip is approximately 12 mm long by 14 mm wide	Each tip is approximately 15 mm long by 20 mm wide	Similar overall dimensions. The minor variations donot introduce any new questions of safety oreffectiveness. Therefore, Substantially Equivalent
Weight	Each tip weighs approximately 0.75 grams.	Each tip weighs approximately 1.2 grams.	Similar weight. The minor variations do not introduceany new questions of safety or effectiveness.Therefore, Substantially Equivalent
COMPARISON OF ENVIRONMENT SPECIFICATIONS
Operating Environment	Room Temperature	Not Known	Although the predicate device did not state itsoperating environment, the proposed device'soperating environment does not raise any newquestions of safety or effectiveness.Therefore, Substantially Equivalent
Storage Environment	Room Temperature	Not indicated	Although the predicate device did not state its storageenvironment, the proposed device's storageenvironment does not raise any new questions ofsafety or effectiveness.Therefore, Substantially Equivalent
COMPARISON OF APPLIED STANDARDS
	Proposed Device: tün® ultrasonic tipsProduct Family	Predicate Device: EDS Ultrasonic TipsK132609
ItemApplicable Standards	• ISO 7405 Second edition 2008-12-15 Dentistry -Evaluation of biocompatibility of medical devicesused in dentistry [Including: Amendment 1 (2013)]resulting in testing to:• ISO 10993-5:2009 / (R) 2014 BiologicalEvaluation of Medical Devices-Part 5: Tests for invitro cytotoxicity• ISO 10993-10:2009 / (R) 2014 BiologicalEvaluation of Medical Devices-Part 10: Tests forirritation and skin sensitization• ISTA 3A General Simulation Performance TestProcedure: Packaged - Products for Parcel DeliverySystem Shipment 150lbs or less	Not indicated / not known/cited	ISO 7405 Second edition is a recognized consensusstandard for product code ELC and ISTA 3A is awidely used standard for evaluatingpackaging/shipping performance. The SummaryStatement of the predicate device did not cite the useof any external standards. However, the proposeddevice's compliance with the cited standards onlybolsters the argument for safety and effectiveness.Therefore, Substantially Equivalent

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Image /page/9/Picture/0 description: The image shows the words "engineered endodontics" stacked on top of each other. The words are in a green sans-serif font with a white outline. The word "engineered" is on the top line, and the word "endodontics" is on the bottom line. There is a registered trademark symbol to the right of the word "endodontics".

tün® ultrasonic tips Product Family TRADIONAL 510(K) SUMMARY

Volume 2

Section 3

Comparison Summary / Conclusions

Engineered endodonics believes the proposed tine predicate, the EDS ultrasonic tips, cleared under K132609, are substanially equivalent in their intended users, intended use environment and indications for use. Furthermore, both devices have the samelequivalent technological characteristics and applicable safety standards. The differences that exist between the devices, relating to their manufacturing methods, coatings and minor shape variations are not significant and are therefore substantially equivalent.

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Regulation Number and Section

§ 872.4850 Ultrasonic scaler.

(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.