(146 days)
No
The device description focuses on mechanical components and lubrication, with no mention of AI or ML technologies.
No
A therapeutic device is one that treats a disease or condition. This device is used for drilling and preparation, which are procedural steps, not treatments in themselves.
No
Explanation: The device, "Titan 3 Low Speed Angle Attachments," is described as being used for "drilling and preparation of dental cavities for restoration," "disking, cavity and crown preps, polishing, post and pin drilling and pin setting." These are all interventional or preparatory procedures, not diagnostic ones. There is no mention of the device being used to identify, measure, or determine the presence or nature of a disease or condition.
No
The device description clearly details physical components made of brass and stainless steel, and describes mechanical functions driven by air and gearing. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is 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." This describes a mechanical procedure performed directly on the patient's body (intraorally).
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. This device does not perform any such testing on samples.
- Device Description: The device description details a mechanical system for driving a dental bur for procedures within the mouth. It does not describe any components or functions related to analyzing biological samples.
Therefore, the Titan 3 Low Speed Angle Attachments are dental instruments used for mechanical procedures within the mouth, not for in vitro diagnostic testing.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
EGS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intraorally
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained dental professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
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
2
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)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| -------------------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------- |
| X Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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:
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.
4
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.
5
| Device | Submission device
Titan 3 Low Speed Angle
Attachments | Predicate device
K983574 StarDental Titan 3
LubeFree Motor Attachments |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Used intraorally by trained
dental professionals for drilling
and preparation of dental
cavities for restoration, such as
fillings, disking, cavity and
crown preps, polishing, post
and pin drilling and pin setting. | Used intraorally by trained
dental professionals for drilling
and preparation of dental
cavities for restoration, such as
fillings. Furthermore, the
intended use extends to
disking, cavity and crown preps,
polishing, post and pin drilling
and pin setting. |
| Material
composition | Brass | Brass |
| Components | Manual latch angle
Autolatch angle
Autochuck angle
Prophy angle | Manual latch angle
Autolatch angle
Autochuck angle
Prophy angle |
| Biocompatibility | Identical material composition
as the predicate | The design incorporates
chrome plated brass for device
construction. The drive shaft
utilizes 300 series stainless
steel. These materials are
known for their corrosion
resistance and are
biocompatible with tissue
encountered during use. |
| Sterilization | Sterilization validation in
accordance with ANSI/AAMI
ST79:2010 & A4:2013,
AAMI/ANSI/ISO 14937:2009
and ANSI/AAMI ST81:2004
(R2010) | Sterilization validation report
references AAMI TIR No. 12-
1994 |
| Performance | Variable up to 20,000 rpm | Variable up to 20,000 rpm |
| Risk analysis | ISO14971:2012 Medical
devices – Application of risk
management to medical
devices | Risk analysis at time of
submission unknown.
Current risk analysis per
ISO14971:2012 – Application of
risk management to medical
devices |
6
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.