The Straight Attachment and Contra Angle Sheath attachments are used with a Low Speed Dental Handpiece that is intended for removing carious material, cavity and crown preparations, finishing tooth preparations, reducing hard tooth structures, restorations and polishing teeth. These attachments are used by authorized persons in the practice of dentistry.

Device Description

The Straight Attachment or the Contra Angle sheath is used to connect between the low-speed air-driven motor and the handpiece head. (1 to 1)

AI/ML Overview

This 510(k) submission (K092053) for the Henry Schein Maxima-M Straight Attachment & Contra Angle Sheath does not contain a study or detailed acceptance criteria for device performance.

Instead, it relies on demonstrating substantial equivalence to predicate devices. This means that the device is considered safe and effective because it is similar in design, materials, and intended use to devices already on the market. In such cases, a detailed performance study with specific acceptance criteria is typically not required, as the safety and effectiveness are established through comparison rather than de novo testing.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
No specific quantitative acceptance criteria are provided in this submission. The basis for acceptance is substantial equivalence to predicate devices.	The device is deemed "as safe and effective as the predicate devices" based on the comparison presented. No quantifiable performance metrics are listed.

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable. There is no mention of a "test set" in the context of a performance study for this device. The submission focuses on a comparison to predicate devices, not on direct performance testing of the new device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. As no performance study with a test set generating new data was conducted, there were no experts establishing ground truth for such a set.

4. Adjudication Method for the Test Set:

Not applicable. No test set or associated adjudication was performed.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

No. The document does not describe an MRMC study. The comparison is made at a device level (similarity of design, materials, intended use) rather than assessing human reader performance.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. This device is a mechanical dental attachment; therefore, an "algorithm only" performance study is irrelevant.

7. Type of Ground Truth Used:

Not applicable/Implicit. The "ground truth" in this context is the regulatory acceptance and established safety/effectiveness of the predicate devices. The new device leverages this existing regulatory record by demonstrating its similarity.

8. Sample Size for the Training Set:

Not applicable. This is a hardware device; machine learning or AI models with training sets are not involved.

9. How Ground Truth for the Training Set Was Established:

Not applicable. As above, no training set or associated ground truth establishment process is relevant for this type of device.

Summary of the Study (or lack thereof):

The "study" in this 510(k) submission is a comparison to predicate devices (MIDWEST STRAIGHT ATTACHMENT-K792445 and NSK CONTRA ANGLE SHEATH-K962540). The applicant, Handpiece Headquarters, asserts that the Henry Schein Maxima-M Straight Attachment & Contra Angle Sheath is substantially equivalent to these legally marketed devices based on:

Device Description: Both the proposed device and the predicate devices are described as connecting between a low-speed air-driven motor and a handpiece head (1 to 1 ratio).
Intended Use: The intended use statement for the Henry Schein Maxima-M Straight Attachment & Contra Angle Sheath is identical in function to what would be expected of the predicate devices: "removing carious material, cavity and crown preparations, finishing tooth preparations, reducing hard tooth structures, restorations and polishing teeth."
Safety and Effectiveness: The conclusion explicitly states: "The Straight Attachment & Contra Angle Sheath are as safe and effective as the predicate devices as cited above."

The FDA's letter (Page 3 of the document) confirms that the FDA "reviewed your Section 510(k) premarket notification of intent to market the device... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This determination signifies that the FDA accepted the applicant's argument of substantial equivalence, meaning no new clinical or performance studies were required for this specific filing.

Summary

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K092053

Image /page/0/Picture/1 description: The image contains the words "Handpiece Headquarters" in a stylized font. The word "Handpiece" is stacked on top of the word "Headquarters". Above the word "Handpiece" is a line that looks like an EKG reading. The text is in black and the background is white.

IG 20 2009

09 d- Device Name; Trade or Proprietary Name: Henry Schein Maxima-M Straight Attachment & Contra Angle Sheath Common Name: Straight Attachment & Contra Angle Sheath Classification Name: Handpiece Contra-And Right-Angle Attachment, Dental (21CFR 872.4200), Class 1, Product Code EGS e- Substantial Equivalency is claimed against the following devices:

MIDWEST STRAIGHT ATTACHMENT-K792445 NSK CONTRA ANGLE SHEATH-K962540

f- Description of the device: The Straight Attachment or the Contra Angle sheath is used to connect between the low-speed air-driven motor and the handpiece head. (1 to 1)

g- Statement of Intended Use:

The Straight Attachment and Contra Angle Sheath attachments are used with a Low Speed Dental Handpiece that is intended for removing carious material, cavity and crow preparations, finishing tooth preparations, reducing hard tooth structures, restorations and polishing teeth. These attachments are used by authorized persons in the practice of dentistry.

h- Safety and effectiveness of the device:

The Straight Attachment & Contra Angle Sheath are as safe and effective as the predicate devices as cited above.

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l -- Conclusion:

Based on the information provided in this submission Handpiece Headquarters believes that the Straight Attachment & Contra Angle Sheath are substantially equivalent to the predicate devices identified.

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Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Mr. Tim Ropchan General Manager Handpiece Headquarters 620 South Placentia Avenue Placentia, California 92870

Re: K092053

Trade/Device Name: Henry Schein Maxima-M Straight Attachment & Contra Angle Sheath for use with Low Speed Handpiece

Regulation Number: 872.4200

Regulation Name: Dental Handpiece and Accessories

Regulatory Class: I

Product Code: EGS

Dated: June 25, 2009

Received: July 7, 2009

Dear Mr. Ropchan:

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 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. Ropchan

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRH ffices/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 yours,

Susan Runov

Susan Runner, D.D.S., M.A. Acting 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):

Device Name: Henry Schein Maxima-M Straight Attachment & Contra Angle Sheath for use with a Low Speed Handpiece

Indications for Use:

These attachments are used by authorized persons in the practice of dentistry.

Prescription Use × (Per 21 CFR 801 Subpart D) Subpart C)

AND/OR

Over-The-Counter Use

(Per 21 CFR 801

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert Betz DDS for Dr. Kevin Mulry
(Division Sign Off)

Page 1 of 1

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K092053

Regulation Number and Section

§ 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.