The 430 SWL 45 and 430 SW 45 air-powered high speed handpieces are used by trained dental professionals for the removal of impacted third molars as well as endodontic and periodontal procedures for which a conventional handpiece would be used.

Device Description

The 430 SWL 45 and 430 SW 45 High-Speed Handpieces are designed with a 45 degree back angled head to facilitate access to the back of the oral cavity. They are designed so that air that expelled from the head of the handpiece is directed out the side of the handpiece head and not directed onto the work area of the bur. The handpieces are intended for use with a friction grip bur that conforms to ISO 1797-1 standards. Recommended air pressure is 30-34 PSI which results in a bur rotation of approximately 400,000 RPM.

The 430 SWL 45 High-Speed Handpiece is a fiber optic, swivel connector type handpiece with a lubefree, ceramic bearing, push button autochuck turbine. The 430 SW 45 High-Speed Handpiece is a non-fiber optic version of the 430 SWL 45 Handpiece.

AI/ML Overview

The DentalEZ Inc., StarDental Division 430 SWL 45 and 430 SW 45 High-Speed Handpieces are dental devices, not an AI or imaging device. Therefore, much of the requested information, such as sample sizes for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, is not applicable.

Here's the available information based on the provided text, focusing on the acceptance criteria and the studies performed to demonstrate equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not list specific numerical acceptance criteria for performance metrics in a table format. Instead, it states that the devices were developed considering applicable technical standards and internal specifications, and their conformance was verified through bench testing. The comparison to predicate devices focuses on similarity in characteristics rather than meeting defined performance thresholds.

Technological Characteristics	Predicate Device Comparison Conclusion	Study/Verification Method
Indication for use	Similar	(Implied through intended use statement and overall submission)
Target population	Identical	(Implied through intended use statement and overall submission)
Design	Similar	Bench testing in TR 468, TR 470
Materials	Identical	(Implied)
Performance	Similar	Bench testing in TR 468, TR 470
Sterility	Identical	Sterilization validation (HIGHPOWER Validation Testing & Lab Services)
Biocompatibility	Identical	(Implied by regulatory standards/predicate comparison)
Mechanical safety	Identical	Bench testing (ISO 14971:2009 for Risk Analysis)
Chemical safety	Identical	(Implied by regulatory standards/predicate comparison)
Energy used and/or delivered	Identical	(Implied)
Compatibility with environment and other devices	Identical	(Implied)
Where used	Identical	(Implied)
Standards met	Similar	Bench testing, conformance to ISO 7785-1, ANSI/AAMI ST79, AAMI/ANSI/ISO 14937
Electrical Safety	Not applicable	(Device is air-powered)

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

Not applicable in the context of this device and study type. Clinical data or test sets as typically understood for AI algorithms are not mentioned. The "tests" referenced are bench tests of the device itself.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. The "ground truth" for this device's performance is established by industrial standards, internal specifications, and physical measurements during bench testing, not expert consensus on medical images or patient outcomes.

4. Adjudication Method

Not applicable. This is not a study requiring adjudication of expert opinions.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No. This type of study is relevant for AI-assisted diagnostic tools. The provided document describes a dental handpiece, not an AI device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

No. This describes a physical medical device, not an algorithm.

7. The type of ground truth used

The "ground truth" for the device's performance is established by:

International Standards: e.g., ISO 7785-1, ANSI/AAMI ST79:2010 & A1:2010 & A2:2011, AAMI/ANSI/ISO 14937:2009, ISO14971:2009.
StarDental Internal Specifications: Used in the development and testing documentation (TR 468, TR 470).
Physical Measurements and Bench Testing Results: Directly observed performance characteristics during testing.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this is not an AI or machine learning device.

9. How the ground truth for the training set was established

Not applicable, as there is no training set mentioned.

Studies that Prove the Device Meets Acceptance Criteria:

The acceptance criteria are implicitly met through the following non-clinical studies and comparisons:

Bench Testing (TR 468): This internal test was developed to determine the performance characteristics of the handpieces, considering StarDental internal specifications and ISO 7785-1, 1997-08-01. This demonstrates the device's mechanical and operational performance against established standards.
Bench Testing (TR 470): This internal test focused on the effectiveness of housing pressure relief slots and the vortex washer, and quantified the air bleed of the handpiece head. It also compared these characteristics with predicate devices. This shows functional design and safety aspects.
Sterilization Validation Studies: Performed by HIGHPOWER Validation Testing & Lab Services, these studies confirmed the effectiveness of sterilization and dry times. They followed ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 and AAMI/ANSI/ISO 14937:2009, ensuring the device meets critical infection control requirements.
Risk Analysis (ISO14971:2009): A risk analysis was conducted according to this standard, indicating that potential risks were identified and mitigated, contributing to the device's safety.
Substantial Equivalence Argument: The core of the 510(k) submission is the argument that the proposed devices are "substantially equivalent" to predicate devices based on similarities in intended use, principles of operation, and functional design. This implies that the performance and safety are comparable to already approved devices. The FDA concurred with this assessment in their letter.

Summary

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KIBOYSS

DentalEZ, Inc. StarDental Division 510(k) Premarket Notification 430 SWL 45 and 430 SW 45 High-Speed Handpieces

Section 5

510(k) Summary

Section 5: 510(k) Summary

Date prepared: March 7, 2013

Company:

DentalEZ Inc., StarDental Division Owner/operator number 2520265

Contact Person:

Jim Watkins, Engineering/Quality Manager Luther Gates, Senior Product Development Engineer 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:

430 SWL 45 and 430 SW 45 High-Speed Handpieces

Classification:

Handpiece, Air-powered, Dental (21 C.F.R. § 872.4200, Product code EFB)

Predicate Device:

430 Series High-Speed Handpiece (K960719) manufactured by StarDental

Ti-Max X450 (K112024) manufactured by Nakanishi, Inc.

Impact Air 45 Handpiece for Endodontic Use (K972375) manufactured by Palisades Dental.

The StarDental 430 SWL 45 and 430 SW 45 High-Speed Handpieces have a similar intended use as the predicate Ti-Max X 450 and Impact Air 45 handpieces. The StarDental 430 SWL 45 and 430 SW 45 High-Speed Handpieces incorporates most of the features of the StarDental 430 Series High-Speed Handpiece, however, the intended use of the proposed device has changed to include removal of impacted third molars, endodontic and periodontal procedures.

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The methods of operation and technology in the proposed devices are similar to all the predicate devices listed above.

Device Description:

Intended Use:

Technological Characteristics:

The 430 SWL 45 and 430 SW 45 High-Speed Handpieces are air-driven, handheld devices which have similar technological characteristics to the predicate devices. The proposed devices are swivel connector type handpieces. They incorporate a lubefree, ceramic bearing, push button autochuck turbine assembly. The 430 SWL 45 High-Speed Handpiece is a fiber optic handpiece while the 430 SW 45 is non-fiber optic.

The proposed devices incorporate a 45 degree back angled head to allow for easier access to the third molar which is same as the Ti-Max X450 and Impact Air 45 handpieces.

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The following table summarizes the comparison of the 430 SWL 45 and 430 SW 45 High-Speed Handpieces to the predicate devices for various technological characteristics.

Technological Characteristics	Predicate Device Comparisonconclusion
Indication for use	Similar
Target population	Identical
Design	Similar
Materials	Identical
Performance	Similar
Sterility	Identical
Biocompatibility	Identical
Mechanical safety	Identical
Chemical safety	Identical
Energy used and/or delivered	Identical
Compatibility with environmentand other devices	Identical
Where used	Identical
Standards met	Similar
Electrical Safety	Not applicable

Non-clinical data:

The 430 SWL 45 and 430 SW 45 High-Speed Handpieces were developed taking into consideration all applicable technical standards, internal specifications and FDA guidance documents. The handpieces conformance with the applicable international and internal standards was verified through bench testing.

TR 468 was developed internally to determine the performance characteristics of the 430 SWL 45 and 430 SW 45 High-Speed Handpieces taking into consideration StarDental internal specifications and ISO 7785-1, 1997-08-01.

TR 470 was developed internally to determine the effectiveness of the housing pressure relief slots and vortex washer on the 430 SWL 45 and 430 SW 45 High-Speed Handpieces. This test request also compared the proposed devices with the predicate devices in order to quantify the air bleed of the handpiece head.

HIGHPOWER Validation Testing & Lab Services of Rochester, NY was contracted to perform sterilization validation and dry time validation studies for the proposed handpieces. These studies were performed in accordance to ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 and AAMI/ANSI/ISO 14937:2009.

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A risk analysis for the 430 SWL 45 and 430 SW 45 High-Speed Handpieces was developed using ISO14971:2009.

Substantial Equivalence:

The determination of substantial equivalence is based on the premise that the proposed device and the predicate devices have similarities in intended use, principles of operation, and functional design.

While the intended use of the proposed device and the 430 Series High Speed Handpiece are different, these differences do not raise any new questions of safety · or effectiveness and are thus considered substantially equivalent.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is simple and uses a black and white color scheme.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

September 25, 2013

DentalEZ Incorporated, StarDental Division Mr. Jim Watkins Engineering/Quality Manager 1816 Colonial Village Lane LANCASTER, PA 17601

Re: K130455

Trade/Device Name: 430 SWL 45 and 430 SW 45 High-Speed Handpicces Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Codc: EFB Dated: August 23, 2013 Received: August 27, 2013

Dear Mr. Watkins:

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 10 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. Insting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH docs 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.

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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 Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Richard C.
Chapman for

Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, 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): K130455

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Device Name: 430 SWL 45 and 430 SW 45 High-Speed Handpieces

Indications for Use:

Prescription Use ਮ (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)

Andrew I. Steen -S	2013.09.25 09:05:37-04'00'
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(Division Sign-Off)	Page 1 of 1
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

510(k) Number:	K130455
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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.