Titan 3 Low Speed Angle Attachments

K162397 · Dentalez, Inc. · EGS · Jan 19, 2017 · Dental

Device Facts

• Record ID: K162397
• Device Name: Titan 3 Low Speed Angle Attachments
• Applicant: Dentalez, Inc.
• Product Code: EGS · Dental
• Decision Date: Jan 19, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Indications for Use

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 Story

Titan 3 Low Speed Angle Attachments are dental handpiece accessories used by trained dental professionals in clinical settings. The device attaches to a pneumatically driven low-speed motor via an adaptor or contra angle. Air-driven motor power is transmitted through a gearing system to the angle attachment, which holds a dental bur. The device performs mechanical drilling, polishing, and cavity preparation. The system includes various styles (manual latch, auto latch, auto chuck, prophy) and lubrication types (lubricated vs. lubefree). The output is the mechanical action of the bur on dental tissue, enabling restorative procedures. The device is autoclavable for reuse.

Clinical Evidence

Bench testing only. Performance testing conducted in accordance with ISO 14457:2012 (Dentistry – Handpieces and motors). Sterilization validation performed per ANSI/AAMI ST79:2010 & A4:2013, AAMI/ANSI/ISO 14937:2009, and ANSI/AAMI ST81:2004 (R2010). Risk analysis conducted per ISO 14971:2012.

Technological Characteristics

Materials: Chrome-plated brass body, 300 series stainless steel drive shafts. Energy source: Pneumatic (air-driven motor). Form factor: Angle attachments for low-speed handpieces. Performance: Variable speed up to 20,000 rpm. Sterilization: Autoclavable; validated per ANSI/AAMI ST79, AAMI/ANSI/ISO 14937, and ANSI/AAMI ST81.

Indications for Use

Indicated for trained dental professionals for intraoral drilling, cavity preparation for restoration (fillings), disking, crown preps, polishing, and post/pin drilling/setting.

Regulatory Classification

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.

Predicate Devices

• Titan 3 LubeFree Motor Attachments (K983574)

Reference Devices

• motor-to-angle adaptor (K960260)
• Dentalube II (K070869)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

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

| <div style="display:flex; align-items:center;"><input checked="" type="checkbox"/>Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><input type="checkbox"/>Over-The-Counter Use (21 CFR 801 Subpart C)</div> |
|--------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
|--------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|

| 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: [phone] Fax: [phone] 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:

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.

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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.

# V. INDICATIONS FOR USE

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.

## 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 device<br>Titan 3 Low Speed Angle<br>Attachments | Predicate device<br>K983574 StarDental Titan 3<br>LubeFree Motor Attachments |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Used intraorally by trained<br>dental professionals for drilling<br>and preparation of dental<br>cavities for restoration, such as<br>fillings, disking, cavity and<br>crown preps, polishing, post<br>and pin drilling and pin setting. | Used intraorally by trained<br>dental professionals for drilling<br>and preparation of dental<br>cavities for restoration, such as<br>fillings. Furthermore, the<br>intended use extends to<br>disking, cavity and crown preps,<br>polishing, post and pin drilling<br>and pin setting. |
| Material<br>composition | Brass | Brass |
| Components | Manual latch angle<br>Autolatch angle<br>Autochuck angle<br>Prophy angle | Manual latch angle<br>Autolatch angle<br>Autochuck angle<br>Prophy angle |
| Biocompatibility | Identical material composition<br>as the predicate | The design incorporates<br>chrome plated brass for device<br>construction. The drive shaft<br>utilizes 300 series stainless<br>steel. These materials are<br>known for their corrosion<br>resistance and are<br>biocompatible with tissue<br>encountered during use. |
| Sterilization | Sterilization validation in<br>accordance with ANSI/AAMI<br>ST79:2010 & A4:2013,<br>AAMI/ANSI/ISO 14937:2009<br>and ANSI/AAMI ST81:2004<br>(R2010) | Sterilization validation report<br>references AAMI TIR No. 12-<br>1994 |
| Performance | Variable up to 20,000 rpm | Variable up to 20,000 rpm |
| Risk analysis | ISO14971:2012 Medical<br>devices – Application of risk<br>management to medical<br>devices | Risk analysis at time of<br>submission unknown.<br>Current risk analysis per<br>ISO14971:2012 – Application of<br>risk management to medical<br>devices |

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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.