(97 days)
Not Found
No
The device description and intended use describe a mechanical dental handpiece powered by compressed air. There is no mention of software, algorithms, or any components that would suggest the use of AI or ML. The performance studies are based on mechanical standards (ISO), not algorithmic performance metrics.
No
The device is used for mechanical procedures like removing carious material and polishing teeth. It is not intended to treat or prevent a disease, nor does it affect the structure or function of the body in a therapeutic manner.
No
The intended use of the PACEMAKER High-Speed Handpiece is for direct treatment (removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations, and polishing teeth), rather than for diagnosis.
No
The device description clearly outlines a physical, hand-held instrument with mechanical components (turbine, channels, connector) made of metal, powered by compressed air. It requires cleaning, lubrication, and sterilization, all indicative of a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
- Device Function: The PACEMAKER High-Speed Handpiece is a dental tool used directly on the patient's teeth and tooth structure for mechanical procedures like removing material, shaping, and polishing. It does not perform any diagnostic tests on samples.
- Intended Use: The intended use clearly describes mechanical procedures on the tooth, not diagnostic testing.
Therefore, based on the provided information, the PACEMAKER High-Speed Handpiece is a dental instrument used for treatment and procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
PACEMAKER High-Speed Handpiece, models PM-MQ and PM-M are intended for removing carious material, reducing hard tooth structure, cavity prepardtion, finishing tooth preparations and restorations and polishing teeth.
Product codes
EFB
Device Description
The PACEMAKER High-Speed Handpiece is a high speed dental handpiece with a lightly textured finish for enhanced grip. It is a hand-held, channeled instrument that is powered by compressed air that is delivered through a hose to an air channel in the handpiece. This impels the turbine in the head of the handpiece to revolve. Other internal channels deliver air and water to the head for cleaning and cooling. Any common dental bur is held in place in the handpiece head by a pushbutton.
There are three major parts which are made metal: a standard turbine, the threaded connector at the back end which attaches to the standard air/water hose in the dental unit, and the internal tubes that carry the chip air and water. These three parts are substantially equivalent to those in the predicate device.
Similar to the predicate device, the PACEMAKER High-Speed Handpiece must be cleaned and lubricated with a quality commercial dental handpiece cleaner/lubricant. It is supplied non-sterile, but must be sterilized before use, as with the predicate device. It will be packaged as a single unit or in multiples.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth/teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed 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
The performance of PACEMAKER High-Speed Handpiece following ISO 7785-1:1997 and ISO 9168:1991 were conducted.
Key Metrics
Not Found
Predicate Device(s)
K052822, K062812, K062740, K093084, K063110, K021250
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summary
SEP 0 9 2010
Summary Prepared Date: 06/01/2010
Submission Sponsor:
KIOIES
Delma Medical Instrument (Guangzhou) Co., Ltd. 17 Xiang Shan Road High and New Technology Industrial Development Zone Guangzhou, Guangdong China 510663
Submission Correspondent:
Mr. Leon Lu Director of Regulatory Affairs
MEDevice Services, LLC 3500 South Dupont Highway Dover, Delaware 19901 USA Phone: 1-877-202-1588 Fax: 1-888-202-8884 Email: info@medeviceservices.com www.medeviceservices.com
Trade/Device Name: PACEMAKER High-Speed Handpiece, models PM-MQ and PM-M
Common or Usual Name: handpiece, air-powered, dental Device Class: 1 Classification Name: handpiece, air-powered, dental Regulation Number: 21 CFR 872.4200 Product Code: EFB Review Panel: Dental
Predicate Device:
- K052822, THUNGER TIGER CORP. . TIGER 100, TIGER 101, TIGER 200, TIGER 201, TIGER 202
- K062812, THUNGER TIGER CORP. . TIGER 300T, TIGER 300K, TIGER 300W, TIGER 300B, TIGER 300N
1
- K062740. JINDELL MEDICAL INSTRUMENTS CO., LTD. . JINDELL HIGH SPPED AIR TURBINE HANDPIECE, MODELS SW, SP, SU, ETU, MU
- K093084, ROLENCE ENT INC. . ROLENCE DENTAL HIGH SPEED HANDPIECE, RHP
- K063110. SHANGHAI DENTAL INSTRUMENT FACTORY . CST61 HIGH SPEED TURBINE HANDPIECE
- K021250, MK-DENT PUSH BUTTON HIGHSPEED HANDPIECE, 4 � HOLES. MODELS HS 2012 (STANDARD HEAD) & HS 2014 (SMALL HEAD)
Device Description:
The PACEMAKER High-Speed Handpiece is a high speed dental handpiece with a lightly textured finish for enhanced grip. It is a hand-held, channeled instrument that is powered by compressed air that is delivered through a hose to an air channel in the handpiece. This impels the turbine in the head of the handpiece to revolve. Other internal channels deliver air and water to the head for cleaning and cooling. Any common dental bur is held in place in the handpiece head by a pushbutton.
There are three major parts which are made metal: a standard turbine, the threaded connector at the back end which attaches to the standard air/water hose in the dental unit, and the internal tubes that carry the chip air and water. These three parts are substantially equivalent to those in the predicate device.
Similar to the predicate device, the PACEMAKER High-Speed Handpiece must be cleaned and lubricated with a quality commercial dental handpiece cleaner/lubricant. It is supplied non-sterile, but must be sterilized before use, as with the predicate device. It will be packaged as a single unit or in multiples.
Intended Use:
PACEMAKER High-Speed Handpiece, models PM-MQ and PM-M are intended for removing carious material, reducing hard tooth structure, cavity prepardtion, finishing tooth preparations and restorations and polishing teeth.
PACEMAKER High-Speed Handpiece carries the following label:
2
CAUTION: Federal (US) law restricts the use of this device to licensed professionals.
Comparison to Predicate Devices:
The PACEMAKER High-Speed Handpiece is essentially the same as or similar to the predicate device in terms of the intended use, design and construction, performance characteristics. The materials used are well-known biocompatible, so no new issues of biocompatibility are raised with regard to this device.
Discussion of Non-Clinical Tests Performed:
The performance of PACEMAKER High-Speed Handpiece following ISO 7785-1:1997 and ISO 9168:1991 were conducted.
Therefore, we conclude that the PACEMAKER High-Speed Handpiece is both safe and effective for its intended use.
Discussion of Clinical Tests Performed:
None
Conclusion:
The proposed device is as safe and effective as the predicate devices. The proposed device has the same intended uses and indications, similar technological characteristics, and principles of operation as its predicate device. The minor differences between the proposed device and its predicate devices raise no new issues of safety or effectiveness. Thus, the PACEMAKER High-Speed Handpiece, models PM-MQ and PM-M are substantially equivalent to its predicate devices.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the name of the department.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Delma Medical Instrument (Guangzhou) Company, Limited C/O Mr. Leon Lu MEDevice Services, LLC 3500 South Dupont Highway Dover, Delaware 19901
SEP 0 9 2010
Re: K101551
Trade/Device Name: PACEMAKER High- Speed Handpiece, models PM-MQ and PM-M Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I (Non-Exempt) Product Code: EFB Dated: August 26, 2010 Received: September 2, 2010
Dear Mr. Lu:
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.
4
Page 2- Mr. Lu
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 reportung (reporting of medical device-related 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
James J. Roberts
for
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name: PACEMAKER High-Speed Handpiece, models PM-MQ and PM-M
Indications for Use:
PACEMAKER High-Speed Handpiece, models PM-MQ and PM-M are intended for removing carious material, reducing hard tooth structure, cavity prepardtion, finishing tooth preparations and restorations and polishing teeth.
PACEMAKER High-Speed Handpiece carries the following label: CAUTION: Federal (US) law restricts the use of this device to licensed professionals.
Over-The-Counter Use AND/OR Prescription Use × (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Ruane
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesion Creat Devices Division of Anesthoology
Infection Control, Dental Devices
510(k) Number: K101531