(89 days)
Not Found
No
The description focuses on mechanical and pneumatic processes for cleaning and lubricating dental handpieces, with no mention of AI or ML technologies.
No
The device is described as a maintenance unit for dental handpieces, intended for cleaning and lubrication. It does not treat or diagnose any medical condition, nor does it affect the structure or function of the body.
No
The device is intended for the cleaning and lubrication of dental handpieces and equipment, not for diagnosing medical conditions.
No
The device description clearly outlines a physical unit with connections, reservoirs, tubes, and magnetic valves, indicating it is a hardware device for cleaning and lubricating dental handpieces.
Based on the provided information, the StarCare Handpiece Maintenance Unit is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The StarCare Handpiece Maintenance Unit is used to clean and lubricate dental handpieces, which are instruments used on the body, not for analyzing samples from the body.
- The intended use clearly describes maintenance of dental instruments. The description focuses on internal cleaning and lubrication of handpieces and attachments used in dentistry.
- There is no mention of analyzing biological samples or providing diagnostic information. The device's function is purely mechanical maintenance.
Therefore, the StarCare Handpiece Maintenance Unit falls under the category of a medical device used for the maintenance of other medical devices, not an IVD.
N/A
Intended Use / Indications for Use
The StarCare Handpiece Maintenance Unit is intended for the internal cleaning. i.e. purging of old lubricant, and the lubrication of air-driven high speed handpieces, electric micromotor attachments and turbines used in dentistry.
StarCare Handpiece Maintenance Unit should be used only after the handpieces have been externally cleaned and prior to sterilization.
Product codes
EFB
Device Description
The StarCare Handpiece Maintenance Unit is used for the cleaning, i.e. purging of old lubricant, and lubrication of lubricated high speed handpieces, electric micromotor attachments and handpiece turbines. The unit consists of two connections for high speed handpieces, one connection for electric micromotor attachments and one connection for handpiece turbine cleaning. The unit supplies cleaner and lubricant to the connection only when a high speed handpiece or electric micromotor attachment is present. The handpiece turbine cleaning function is independent of the high speed handpiece and electric micromotor attachment cleaning and lubrication function.
Two reservoirs within the unit supply the cleaner and lubricant to the individual stations. These reservoirs are clearly marked regarding the contents of the reservoir. The cleaner and lubricant are delivered to the high speed handpiece and electric micromotor attachment connection via tubes controlled by the activation of magnetic valves. The liquid is dispensed by pressurized air to the high speed handpiece and electric micromotor attachment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentistry
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
DEC 2 8 2009
510(k) Premarket Notification StarCare Handpiece Maintenance Unit Section 5
510(k) Summary
Section 5: 510(k) Summary
Company:
DentalEZ Inc., StarDental Division Owner/operator number 2520265
Contact Person:
Dale Braas, Engineering/Quality Manager Kay Engle, Regulatory Affairs Supervisor DentalEZ Inc., StarDental Division 1816 Colonial Village Lane Lancaster, PA 17601 Phone: (717) 291-1161 Fax: (717) 391-2757
Proprietary/Trade Name:
StarCare Handpiece Maintenance Unit
Classification:
Handpiece, Air-powered, Dental (21 C.F.R. § 872.4200, Product code EFB)
Predicate Device:
Statmatic, manufactured by SciCan LTD. Ontario, Canada (K073319) Lubrina, manufactured by J. Morita USA, Inc., Irvine, CA. (K070074) Assistina, manufactured by A-Dec Incorporated, Newburg, OR (K010127)
StarCare Handpiece Maintenance Unit has similar intended uses, similar methods of operation and similar technology to the previously cleared predicate devices. Although minor differences exist between the StarCare Handpiece Maintenance Unit and predicate devices, they do not present any new questions of safety or effectiveness.
Device Description:
The StarCare Handpiece Maintenance Unit is used for the cleaning, i.e. purging of old lubricant, and lubrication of lubricated high speed handpieces, electric micromotor attachments and handpiece turbines. The unit consists of two connections for high speed handpieces, one connection for electric micromotor
1
attachments and one connection for handpiece turbine cleaning. The unit supplies cleaner and lubricant to the connection only when a high speed handpiece or electric micromotor attachment is present. The handpiece turbine cleaning function is independent of the high speed handpiece and electric micromotor attachment cleaning and lubrication function.
Two reservoirs within the unit supply the cleaner and lubricant to the individual stations. These reservoirs are clearly marked regarding the contents of the reservoir. The cleaner and lubricant are delivered to the high speed handpiece and electric micromotor attachment connection via tubes controlled by the activation of magnetic valves. The liquid is dispensed by pressurized air to the high speed handpiece and electric micromotor attachment.
Intended Use:
The StarCare Handpiece Maintenance Unit is intended for the internal cleaning. i.e. purging of old lubricant, and the lubrication of air-driven high speed handpieces, electric micromotor attachments and turbines used in dentistry.
StarCare Handpiece Maintenance Unit should be used only after the handpieces have been externally cleaned and prior to sterilization.
Technological Characteristics:
The StarCare Handpiece Maintenance Unit is a self-contained cleaning and lubrication system that can clean and lubricate up to two high speed handpieces and one electric micromotor attachment at the same time. Indicator lights on the front panel of the unit, show which handpiece station is currently being serviced. The cleaner and lubricant are pumped from separate reservoirs located within the unit. The unit detects if a high speed handpiece or electric micormotor attachment is connected and delivers cleaner and lubricant only to the occupied stations. After cleaning and lubrication cycle a burst of compressed air is forced into the high speed handpiece or electric micromotor attachment to purge the instrument of excess cleaner, lubricant and debris.
The handpiece turbine cleaning function of the StarCare Handpiece Maintenance Unit is independent of the high speed handpiece and electric micromotor attachment cleaning and lubrication. With the front door of the unit oven, the operator holds the handpiece in place during the handpiece turbine cleaning process. After the cleaning and lubrication cycle a burst of compressed air is forced into the chuck to purge the excess cleaner, lubricant and debris. An indicator light on the front panel illuminates during the cleaning process.
2
The following table summarizes the comparison of the StarCare Handpiece Maintenance Unit to the predicate devices for various technological characteristics.
| Technological Characteristics | Predicate Device Comparison
conclusion |
|-----------------------------------------------------|-------------------------------------------|
| Indication for use | Similar |
| Target population | Identical |
| Design | Similar |
| Materials | Similar |
| Performance | Similar |
| Sterility | Identical |
| Biocompatibility | Identical |
| Mechanical safety | Identical |
| Chemical safety | Identical |
| Energy used and/or delivered | Identical |
| Compatibility with environment
and other devices | Identical |
| Where used | Identical |
| Standards met | Similar |
| Electrical Safety | Similar |
Substantial Equivalence:
The determination of substantial equivalence is based on the premise that the proposed device and the predicate devices have the same intended use, similar technology and design.
3
Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Ms. Kay Engle Regulatory Affairs Supervisor DentalEZ Incorporated StarDental Division 1816 Colonial Village Lane Lancaster, Pennsylvania 17601
JAN 2 1 2010
Re: K093072
Trade/Device Name: StarCare Handpiece Maintenance Unit Regulation Number: 21CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: September 29, 2009 Received: September 30, 2009
Dear Ms. Engle:
This letter corrects our substantially equivalent letter of December 28, 2009.
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 (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.
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 - Ms. Engle
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 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
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: StarCare Handpiece Maintenance Unit
Indications for Use:
The StarCare Handpiece Maintenance Unit is intended for the internal cleaning, i.e purging of old lubricant, and the lubrication of air-driven high speed handpieces, electric micromotor attachments and turbines used in dentistry.
StarCare Handpiece Maintenance Unit should be used only after the handpieces have been externally cleaned and prior to sterilization.
CAUTION: Federal law restricts this device to sale by or on the order of a dentist.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
RSBER DDS for Dr. K.P. Mulry (Acting)
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
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510(k) Number: K093072