(78 days)
The Prophy Star 3 Hygiene Handpiece is a low speed, pneumatically driven, hand-held device intended for use by trained dental professionals for performing dental prophylaxis.
The prophy handpiece is used by trained dental professionals to perform dental prophylaxis.
The Prophy Star 3 Hygiene Handpiece is a low speed, pneumatically driven, hand-held device intended for use by trained dental professionals for performing dental prophylaxis. The handpiece uses either an ISO standard Doriot style reusable Prophy angle or a ISO standard Doriot style disposable angle. The Prophy Star 3 Hygiene Handpiece is a Lube Free handpiece requiring no lubrication.
The provided text describes a 510(k) premarket notification for a dental handpiece, the Prophy Star 3 Hygiene Handpiece. It focuses on establishing substantial equivalence to a predicate device based on intended use, technology, and design.
However, the document does not contain information related to acceptance criteria, a specific study proving device performance against acceptance criteria, or any of the detailed aspects of a clinical or performance study as requested in the input.
Therefore, I cannot provide the requested table and detailed information about acceptance criteria and study particulars for the Prophy Star 3 Hygiene Handpiece based on the given text.
The document is a regulatory approval letter from the FDA (June 15, 2007) and a 510(k) summary (May 21, 2007). These types of documents typically attest to substantial equivalence based on comparisons to existing devices and adherence to general safety and performance standards, rather than presenting detailed multi-reader multi-case studies or standalone algorithm performance data.
Here's what I can infer from the available information, but it does not address the specific questions about acceptance criteria or a dedicated performance study:
- Device: Prophy Star 3 Hygiene Handpiece
- Intended Use: For use by trained dental professionals for performing dental prophylaxis.
- Predicate Device: StarDental Prophy Star II Hygiene Handpiece Micro Motors PHP 100 Prophy Handpiece (K896877)
- Basis for Substantial Equivalence: Same intended use, similar technology and design, same means of operation, and used for the same procedures. Improvements were made to enhance handpiece performance while maintaining safety. This implies that the new device is expected to perform at least as well as the predicate device.
Without a performance study or clinical trial section in the provided text, I cannot answer the specific quantitative questions.
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Image /page/0/Picture/1 description: The image shows the logo for DentalEZ Group. The logo is in black and white and features the words "DentalEZ" in a bold, sans-serif font. Below "DentalEZ" is the word "GROUP" in a smaller font. To the right of the text is a stylized graphic of two curved lines that form a partial circle.
StarDental Products 1816 Colonial Village Lane Lancaster, PA 17601-5864 717/291-1161 Fax 717/391-2757 IN 1 5 2007 www.dentalez.com
510(k) Summary Prophy Star 3 Hygiene Handpiece May 21, 2007
Company:
DentalEz Inc., StarDental Division Owner/operator number 2520265
Contact Person:
William Guscott Engineering Manager DentalEz Inc., StarDental Division 1816 Colonial Village Lane Lancaster, PA 17601 Phone: (717) 291-1161, ext. 4319 Fax: (717) 391-2757
Proprietary/Trade Name:
Prophy Star 3 Hygiene Handpiece
Common/Usual Name:
Dental Handpiece
Classification:
Dental handpiece and accessories (per 21 CFR 872.4200)
Predicate Device:
StarDental Prophy Star II Hygiene Handpiece Micro Motors PHP 100 Prophy Handpiece (K896877)
Image /page/0/Picture/16 description: The image shows the logo for StarDental. The text "StarDental" is written in a bold, sans-serif font. To the right of the text is a stylized star symbol, which is partially filled in with black.
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Device Description/Intended Use:
The Prophy Star 3 Hygiene Handpiece is a low speed, pneumatically driven, hand-held device intended for use by trained dental professionals for performing dental prophylaxis. The handpiece uses either an ISO standard Doriot style reusable Prophy angle or a ISO standard Doriot style disposable angle. The Prophy Star 3 Hygiene Handpiece is a Lube Free handpiece requiring no lubrication.
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. Both devices have the same means of operation and are used for the same procedures. Improvements made to the proposed device were initiated to improve the handpiece performance while maintaining the safety of the device.
Image /page/1/Picture/4 description: The image shows the logo for StarDental. The text "StarDental" is written in a bold, sans-serif font. To the right of the text is a stylized star symbol, which is partially filled in with black. The logo is simple and modern.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, superimposed over a caduceus. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. William Guscott Engineering Manager DentalEZ, Incorporated StarDental Division 1816 Colonial Village Lane Lancaster, Pennsylvania 17601
JUN 1 5 2007
Re: K070869
Trade/Device Name: Prophy Star 3 Hygiene Handpiece Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: May 30, 2007 Received: May 31, 2007
Dear Mr. Guscott:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 - Mr. Guscott
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,
Sufite y. Michaud m.d.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, 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): K.070869
Device Name: _Prophy Star 3 Hygiene Handpiece
Indications for Use:
The prophy handpiece is used by trained dental professionals to perform dental prophylaxis.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Susan Runne | |
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Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
| 510(k) Number: | K020869 |
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§ 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.