Titan 3 Low Speed Angle Attachments are used intraorally by trained dental professionals for drilling and preparation of dental cavities for restoration, such as fillings, as well as disking, cavity and crown preps, polishing, post and pin drilling and pin setting.

Device Description

The proposed angles are attached to a pneumatically driven low speed motor via the use of either a motor-to-angle adaptor (K960260) or 16:1 contra angle (preamendment). Air supplied to the motor (K960260) drives a gearing system through the adaptor or contra angle to the angle attachment. A torque multiplier can be used between the motor and motor-to-angle adaptor or contra angle to reduce the rpms from the motor while increasing the torque. A dental bur is inserted into the angle to perform the procedure.

There are four different angle styles that will marketed under the names Titan 3 LubeFree Angles, Titan 3 Lubricated Angles, and Five Star Prophy Angles with some variations within each style. The main differences between the styles of the proposed angles are in the mechanical chucking mechanism of the angle and prophy, the composition of the outside plating of the angle attachment and the lubrication that may be needed to maintain the attachment.

The angles are constructed of brass, which is chrome plated The internal drive gears are constructed of stainless steel.

The lubricated angles, consisting of a ball bearing manual latch angle, ball bearing auto latch angle, ball bearing auto chuck friction grip angle and a Prophy angle require daily lubrication using the recommended lubricant, Dentalube II, which is manufactured by StarDental (K070869).

The lubefree angles, consisting of a ball bearing manual latch angle, ball bearing auto latch angle, ball bearing auto chuck friction grip angle and a Prophy angle, are lubricated during the assembly process and require no further lubrication by the user.

All proposed angles are autoclavable.

AI/ML Overview

This looks like a 510(k) premarket notification for a dental device, not an AI/ML device. The document describes a traditional medical device (dental handpiece attachments) and its comparison to a predicate device for substantial equivalence. Therefore, many of the requested categories for AI/ML device studies (like sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, etc.) are not applicable and are not present in this document.

However, I can extract the relevant information regarding acceptance criteria and the studies performed for this specific device.

Acceptance Criteria and Device Performance (as applicable to a non-AI/ML device):

Acceptance Criteria Category	Metric	Reported Device Performance
Functional / Performance	Operates at variable speeds up to 20,000 rpm (matching predicate).	Variable up to 20,000 rpm.
Biocompatibility	Identical material composition as predicate (brass, stainless steel for drive shaft), known for corrosion resistance and biocompatibility.	Identical material composition as the predicate; construction uses chrome plated brass and 300 series stainless steel drive shaft.
Sterilization	Validation in accordance with ANSI/AAMI ST79:2010 & A4:2013, AAMI/ANSI/ISO 14937:2009, and ANSI/AAMI ST81:2004 (R2010) (matching predicate's previous validation, updated for current standards).	Sterilization validation performed in accordance to ANSI/AAMI ST79:2010 & A4:2013, AAMI/ANSI/ISO 14937:2009, and ANSI/AAMI ST81:2004 (R2010).
Mechanical/Physical	Method of operation, use of same base materials, lubrication requirements, style of angles, and autoclavability are consistent with the predicate device. Constructed of brass (chrome plated), internal drive gears of stainless steel.	Consistent with predicate, constructed of brass (chrome plated) with stainless steel internal drive gears.
Risk Management	Risk analysis performed per ISO14971:2012.	Risk analysis for the Angle Attachments for Low-Speed Handpieces was developed using ISO14971:2012.

Study Information (as applicable to a non-AI/ML device):

Sample sizes used for the test set and the data provenance: Not explicitly stated in this document for individual tests, as it's a traditional device submission. The "test set" would refer to the physical devices undergoing testing. The provenance is from DentalEZ, Inc., StarDental Division, Lancaster, PA, USA. The testing is prospective for the specific devices being submitted.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For this type of device, "ground truth" refers to physical measurements and adherence to engineering and performance standards, not expert interpretations of data.
Adjudication method for the test set: Not applicable. Performance is measured against objective engineering and regulatory standards, not expert adjudication.
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: Not applicable, as this is not an AI device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI device.
The type of ground truth used:
- Functional/Performance: Metrological measurements of RPMs and operational characteristics against established engineering specifications and the predicate device's performance.
- Biocompatibility: Material specifications and compliance with known biocompatible materials.
- Sterilization: Results from sterilization validation cycles against microbiology standards (e.g., achieving sterility assurance level).
- Mechanical: Physical inspection, material analysis, and functional tests (e.g., torque, durability).
- Risk Analysis: Compliance with the methodology outlined in ISO14971:2012.
The sample size for the training set: Not applicable, as this is not an AI/ML device. There is no "training set" in the context of an algorithm.
How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

Overall Study Conclusion:

The document explicitly states: "Based upon the comparison of technological characteristics, demonstrated through bench testing and intended use, the Titan 3 Low Speed Angle Attachments are substantially equivalent to the predicate devices."

Specific Studies/Tests Mentioned:

Performance testing: In accordance with ISO 14457:2012 Dentistry – Handpieces and motors.
Sterilization validation: In accordance with ANSI/AAMI ST79:2010 & A4:2013, AAMI/ANSI/ISO 14937:2009, and ANSI/AAMI ST81:2004 (R2010).
Risk analysis: Developed using ISO14971:2012.
Bench testing: Implied for comparison of technological characteristics.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 19, 2017

DentalEZ, Inc. Dan Laskowitz Engineering/Quality Manager 1816 Colonial Village Lane Lancaster, Pennsylvania 17601

Re: K162397

Trade/Device Name: Titan 3 Low Speed Angle Attachments Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I Product Code: EGS Dated: December 5, 2016 Received: December 22, 2016

Dear Dan Laskowitz:

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. 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.

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Dan Laskowitz

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K162397

Device Name

Titan 3 Low Speed Angle Attachments

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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| X Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image contains the logo for DentalEZ, Inc., StarDental Division. The logo features a circular design with overlapping arcs in shades of brown, gray, and green. To the right of the circular design is the text "DentalEZ" in a bold, sans-serif font, with the words "INTEGRATED SOLUTIONS" in a smaller font underneath. Below the logo is the text "DentalEZ, Inc.," followed by "StarDental Division".

l. SUBMITTER

DentalEZ Inc., StarDental Division 1816 Colonial Village Lane Lancaster, PA 17601 Phone: (717) 291-1161 Fax: (717) 391-2757 Contact Person: Dan Laskowitz, Engineering/Quality Manager Kay Engle, Regulatory Affairs/QA Supervisor August 4, 2016

II. DEVICE

Name of the Device: Titan 3 Low Speed Angle Attachments

Common or Usual Name: Angle Attachments for Low-Speed Handpiece Classification Name: Dental Handpiece and Accessories (21 C.F.R. § 872.4200,

Product code EGS)

Regulatory Class: I Product Code: EGS

III. PREDICATE DEVICE

Titan 3 LubeFree Motor Attachments (K983574)

IV. DEVICE DESCRIPTION:

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The angles are constructed of brass, which is chrome plated The internal drive gears are constructed of stainless steel.

All proposed angles are autoclavable.

V. INDICATIONS FOR USE

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:

The Angle Attachments for Low-Speed Handpieces and the predicate devices are both attached to an air-driven low speed motor assembly. The proposed devices and the predicate devices have the same technological characteristics:

Method of operation
Use of the same base materials .
Lubrication requirements ●
Style of angles
Autoclavable

The difference between the proposed devices and the predicate devices are

. OEM manufacturer
The following table summarizes the comparison of the Angle Attachments for Low-Speed Handpieces to the predicate devices for indications for use and technological characteristics.

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Device	Submission deviceTitan 3 Low Speed AngleAttachments	Predicate deviceK983574 StarDental Titan 3LubeFree Motor Attachments
Indications for Use	Used intraorally by traineddental professionals for drillingand preparation of dentalcavities for restoration, such asfillings, disking, cavity andcrown preps, polishing, postand pin drilling and pin setting.	Used intraorally by traineddental professionals for drillingand preparation of dentalcavities for restoration, such asfillings. Furthermore, theintended use extends todisking, cavity and crown preps,polishing, post and pin drillingand pin setting.
Materialcomposition	Brass	Brass
Components	Manual latch angleAutolatch angleAutochuck angleProphy angle	Manual latch angleAutolatch angleAutochuck angleProphy angle
Biocompatibility	Identical material compositionas the predicate	The design incorporateschrome plated brass for deviceconstruction. The drive shaftutilizes 300 series stainlesssteel. These materials areknown for their corrosionresistance and arebiocompatible with tissueencountered during use.
Sterilization	Sterilization validation inaccordance with ANSI/AAMIST79:2010 & A4:2013,AAMI/ANSI/ISO 14937:2009and ANSI/AAMI ST81:2004(R2010)	Sterilization validation reportreferences AAMI TIR No. 12-1994
Performance	Variable up to 20,000 rpm	Variable up to 20,000 rpm
Risk analysis	ISO14971:2012 Medicaldevices – Application of riskmanagement to medicaldevices	Risk analysis at time ofsubmission unknown.Current risk analysis perISO14971:2012 – Application ofrisk management to medicaldevices

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VII. PERFORMANCE DATA

Performance testing was completed in accordance with ISO 14457:2012 Dentistry – Handpieces and motors.

Sterilization validation for the sterilization of the handpieces was performed in accordance to ANSI/AAMI ST79:2010 & A4:2013, AAMI/ANSI/ISO 14937:2009 and ANSI/AAMI ST81:2004 (R2010).

A risk analysis for the Angle Attachments for Low-Speed Handpieces was developed using ISO14971:2012.

VIII. CONCLUSION

Based upon the comparison of technological characteristics, demonstrated through bench testing and intended use, the Titan 3 Low Speed Angle Attachments are substantially equivalent to the predicate devices.

Regulation Number and Section

§ 872.4200 Dental handpiece and accessories.

(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.