Endo-Express® Handpiece is indicated for the removal of dentin, shaping and obturation of the root canal. This application area extends to endodontic procedures using NiTi or stainless steel endodontic instruments intended by the manufacturer for use in the mechanical preparation of root canals.

Device Description

Endo-Express® Handpiece is a reciprocating handpiece for use with NiTi or stainless steel instruments during endodontic procedures. The handpiece is driven by an air motor. The steps required to properly operate the handpiece are: push button to open chuck, insert instrument handle into chuck, release button to close chuck, run handpiece. After use, the handpiece should be lubricated and autoclaved. The contents of the kit are 1 Endo-Express® Handpiece, 1 Lubricant bottle, 1 nozzle attachment.

AI/ML Overview

The provided document is a 510(k) summary for the Endo-Express® Handpiece, stating its substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a dedicated study with the specific components you requested (such as sample sizes, expert qualifications, and MRMC studies).

Here's a breakdown of why this information isn't present in the provided text:

Nature of the Document: This is a premarket notification (510(k)) seeking clearance based on substantial equivalence. For Class I and many Class II devices, clinical trials with formal acceptance criteria, statistical analyses, and ground truth establishment are often not required if substantial equivalence to a legally marketed predicate device can be demonstrated through performance testing, comparison of technological characteristics, and intended use.
"Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as Follows: Not Applicable" (Section 7): This explicitly states that specific non-clinical tests were not performed in a way that would require detailed reporting of acceptance criteria and results in this summary. It implies that the demonstration of substantial equivalence relied on other factors, primarily comparison of intended use and technological characteristics to the predicate.
"Discussion of Clinical Tests Performed: Not Applicable" (Section 8): This confirms that no clinical studies were performed for the purpose of this 510(k) submission. Therefore, there would be no data on sample sizes, expert-established ground truth, MRMC studies, or standalone algorithm performance.

Based on the provided document, the following information is available for your request:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
Not explicitly stated in the document as formal acceptance criteria for a new study.	The device is considered substantially equivalent to the predicate device (TEP E4R, K#962540) based on similar intended use and technological characteristics.

(Note: The document implies the "acceptance" is based on the device having similar characteristics and intended use to the predicate. There are no numerical performance metrics or thresholds explicitly defined as acceptance criteria for this specific submission.)

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Sample Size for Test Set: Not applicable. No test set for performance comparison was described as part of a new study in this submission.
Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No ground truth establishment by experts for a test set was described in this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. No MRMC study was performed or described. This device is a mechanical dental handpiece, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a mechanical dental handpiece, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

Not applicable.

8. The sample size for the training set:

Not applicable.

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

Not applicable.

Summary of the study that proves the device meets the acceptance criteria:

The document states, "Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as Follows: Not Applicable" and "Discussion of Clinical Tests Performed: Not Applicable."

Instead of a specific performance study, the substantial equivalence was demonstrated by:

Comparison of Intended Use: The Endo-Express® Handpiece has the same intended use as the predicate device (TEP E4R).
Comparison of Technological Characteristics: The device has similar technological characteristics to the predicate, with the main differences being cosmetic appearance and maximum allowable motor speed. The key functional characteristics (latch type, file type, motor connection, reduction ratio) are identical to the predicate.

The "study" proving the device meets the implicit acceptance criteria (i.e., being substantially equivalent to a legally marketed predicate) is primarily a direct comparison of specifications and intended use outlined in Section 6, rather than a clinical or detailed non-clinical performance study with explicit acceptance criteria and results.

Summary

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MAR 1 6 2012

Exhibit #1

510(k) SUMMARY

ﺎ

This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K111541.

Submitter's Identification: 1.

Essential Dental Systems

89 Leuning Street
South Hackensack, NJ 07606
Date Summary Prepared: June 18, 2011
Date Summary Revised: February 13th, 2012
Contact: Mr. Jeffrey Wan
Contact Phone #: 201-487-9090 ext. 118
Contact Fax #: 201-487-5120

2. . Name of the Device:

: --

Trade name: Endo-Express® Handpiece

Common name: dental handpiece
Classification name: dental handpiece (21 CFR 872.4200, Product Code EGS)

3. Predicate Device Information:

1. TEP E4R, K#962540, NSK Nakanishi, Tochigi, Japan

4. · Device Description:

The contents of the kit are

1 Endo-Express® Handpiece
1 Lubricant bottle
1 nozzle attachment

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5. Intended Use:

ー・・・・

6. Comparison to Predicate Devices:

The subject device is similar to the TEP E4R in that they are both 90³ reciprocating handpieces used in conjunction with various endodontic instrumentation systems for the treatment of root canals. The directions for use for these materials are nearly identical.

The subject device differs from the TEP E4R in cosmetic appearance and the max allowable motor speed.

Characteristic	Endo-Express®	TEP E4R
Max Motor Speed	$12,000min^{-1}$	$40,000min^{-1}$
Latch Type	Push Button Chuck	Push Button Chuck
File Type	hand files	hand files
Motor Connection	E-Type air or electric motor	E-Type air or electric motor
Reduction Ratio	4:1	4:1

Discussion of Non-Clinical Tests Performed for Determination of 7. Substantial Equivalence are as Follows:

Not Applicable

Discussion of Clinical Tests Performed: 8.

Not Applicable

9. Conclusions:

Endo-Express® Handpiece has the same intended use and similar technological characteristics as the predicate device. Thus, Endo-Express® Handpiece is substantially equivalent to the predicate device.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

MAR 1 6 2012

Mr. Jeffrey Wan Research and Development Manager Essential Dental Systems, Incorporated 89 Leuning Street, Suite 8 South Hackensack, New Jersey 07606

Re: K111541
Trade/Device Name: Endo Express® Handpiece Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EGS Dated: March 7, 2012 · Received: March 8, 2012

Dear Mr. Wan:

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. Please note: CDRH does 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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Page 2- Mr. Wan

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/CDRHOffices/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,

h fac

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

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Exhibit B

Indications for Use

Page 1 of 1

510(k) Number (if known): K111541

Device Name: Endo Express® Handpiece

Indications for Use:

Prescription Use X (Per 21 CFR 801 Subpart D)

Over the Counter Use (Per 21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Pearson

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

510(k) Number. K111541

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.