This Handpiece is intended for removing carious material, cavity preparations, finishing tooth preparations, reducing hard tooth structures, restorations and polishing teeth.

Device Description

The canister handpiece is a complete dental handpiece that includes the turbine (push button & a screw type). The handpiece is fully functional and is being offered in a 4 hole version.

High pressured air directly impacts the blade pockets of the impeller through an air intake tube located inside the handpiece body, which causes the air turbine to rotate at a high speed. The dental cutting bur connects to the turbine's sharik (spindle), which rotates at the same speed as the impeller. Cooling water flows through an inlet water tube at high pressure and blows out at an angle near the dental cutting bur to reduce temperature at cutting area.

AI/ML Overview

This document is a 510(k) summary for the Henry Schein/HHC/SCORE Canister Handpiece, indicating a premarket notification for a dental device. The primary finding is that the device is "substantially equivalent" to a predicate device. This type of submission relies on demonstrating equivalence rather than conducting new clinical studies with established acceptance criteria and detailed performance reporting.

Therefore, the information typically found in a study proving a device meets acceptance criteria (like detailed performance metrics, sample sizes, ground truth establishment, MRMC studies, etc.) is not present in this document.

Here's an analysis based on the provided text, highlighting the absence of the requested clinical study data:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable/Not provided.
The document states: "The canister handpiece is as safe and effective as the predicate device as cited above." This is a statement of substantial equivalence, not a report of specific performance metrics against pre-defined acceptance criteria from a clinical study. No specific quantitative or qualitative acceptance criteria are listed, and no detailed performance data (e.g., accuracy, precision, durability, success rates) are reported.

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

Not applicable/Not provided.
Since no new clinical study demonstrating performance against acceptance criteria was conducted or reported, there is no test set sample size or data provenance information. The basis for equivalence is a comparison of design and functional principles with existing predicate devices.

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

Not applicable/Not provided.
No test set requiring expert ground truth establishment is mentioned.

4. Adjudication Method for the Test Set

Not applicable/Not provided.
No test set requiring adjudication is mentioned.

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

Not applicable/Not provided.
No MRMC study was conducted or reported. The document focuses on device design and intended use equivalence, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Not applicable/Not provided.
This device is a mechanical dental handpiece, not an AI algorithm. Therefore, a standalone performance study in the context of an algorithm is irrelevant.

7. Type of Ground Truth Used

Not applicable/Not provided.
There is no "ground truth" mentioned in the context of a clinical performance study. The ground truth for this submission is the established safety and effectiveness of the predicate devices.

8. Sample Size for the Training Set

Not applicable/Not provided.
No training set is mentioned as this is a physical device, not a machine learning model.

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

Not applicable/Not provided.
As there is no training set for an algorithm, this question is not relevant.

Summary of Device Rationale from the Document:

The basis for market clearance for the Henry Schein Canister Handpiece is substantial equivalence to an already legally marketed predicate device (SUPER-AIR S & SUPER-AIR U Handpiece Models manufactured by PENG LIM ENTERPRISE CO., Ltd.).

The document describes the device and its intended use, then states: "The canister handpiece is as safe and effective as the predicate device as cited above." This implies that by being similar in design, function, and intended use to a device already deemed safe and effective, no new, extensive clinical studies demonstrating specific performance against novel acceptance criteria were required for this 510(k) submission.

The "study" in this context is the comparison against the predicate device, not a clinical trial.

Summary

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Image /page/0/Picture/0 description: The image shows a handwritten string of characters. The characters appear to be "K080682". The writing is in black ink on a white background. The characters are somewhat stylized and connected.

Image /page/0/Picture/1 description: The image shows the logo for "Handpiece Headquarters". The text is in a bold, sans-serif font, with the word "Handpiece" stacked on top of the word "Headquarters". There is a line below the text, and some other text below the line, but it is too small to read. The logo is black and white.

510(K) SUMMARY:

SEP 1 1 2008

AIR-POWERED HANDPIECE MODELS: HENRY SCHEIN/ HHC/ SCORE Canister Handpiece. (Identical Handpiece/ 3 difference labels) _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

510K
a- Submitted by:	HANDPIECE HEADQUARTERS
	2284 N. GLASSELL ST. UNIT A. ORANGE, CA.92865
	Tel. 714-685-3070 Fax. 714-921-1852
b- Contact person:	Tina Steffanie-Oak
	Tel. 717-335-7230, ext. 4150 Fax. 717-335-7240
	Email: tina.steffanie-oak@henryschein.com
c- Date summary prepared:	03/06/08
d- Device Name:
Trade or Proprietary Name:	HENRY SCHEIN Canister Handpiece
Common Name:	Air-Power Dental Handpiece
Classification Name:	Dental Handpiece and accessories
	(21CFR 872.4200)
	Class: I
Product Code:	EFB "Handpiece, Air-powered, Dental"
e- Substantial Equivalency is claimed against the following device:
	SUPER-AIR S: Standard, 400,000 rpm, Wrench Type Chuck
	SUPER-AIR: Standard, 400,000 rpm, push button chuck.
	Products of Peng Lim Enterprise Co., Ltd. (K062947)
f- Description of the device:

f- Description of the device:

The canister handpiece is a complete dental handpiece that includes the turbine (push button & a screw type). The handpiece is fully functional and is being offered in a 4 hole version.

. . . .

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which rotates at the same speed as the impeller. Cooling water flows through an inlet water tube at high pressure and blows out at an angle near the dental cutting bur to reduce temperature at cutting area.

g- Statement of Intended Use:

This Handpiece is used by authorized persons in the practice of dentistry.

This Handpiece is intended for removing carious material, reducing hard tooth structures, cavity preparations, finishing tooth preparations, restorations and polishing teeth.

h- Safety and effectiveness of the device:

The canister handpiece is as safe and effective as the predicate device as cited above.

I – Conclusion:

Based on the information in the notification Handpiece Headquarters believes that this Canister Handpiece is substantially equivalent to the claimed predicate device. ( SUPER-AIR S & SUPER-AIR U Handpiece Models manufacture by PENG LIM ENTERPRISE CO., Ltd.)

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms.

SEP 1 1 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Tina Steffanie-Oak Senior Regulatory Specialist Handpiece Headquaters Incorporated 2284 North Glassell Street, Unit A Orange, California 92856

Re: K080682

Trade/Device Name: Henry Schein Canister Handpiece Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Codc: EFB Dated: September 9, 2008 Received: September 10, 2008

Dear Ms. Steffanie-Oak:

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 - Ms. Steffanie-Oak

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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

V.H. Arnold's Penders. foell

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): K080682

Device Name: Henry Schein Canister Handpiece

Indications for Use:

The Dental Handpiece is used by authorized persons in the practice of dentistry.

This Handpiece is intended for removing carious material, cavity preparations, finishing tooth preparations, reducing hard tooth structures, restorations and polishing teeth.

AND/OR Prescription Use______________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801 Subpart D)

Over-The-Counter Use

(Per 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)

Page 1 of 1

Susan Pearson

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

510(k) Number: K080682

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.