The ORTHODONTIC CERAMIC BRACKETS are bonded to teeth to apply pressure to the tooth, transmitted through a flexible orthodontic wire, to alter the tooth position. The dimpled, beveled bracket base includes rhomboid and "torque-in-the-base" features. The modified ceramic, orthodontic brackets have indented walls and are available with or without glass coating in the wire slot. The modified brackets are more transparent than the predicate device.

AI/ML Overview

The provided text is a 510(k) summary for Orthodontic Ceramic Brackets. It does not contain information about acceptance criteria or a study proving device performance in the context of an AI/medical device study with performance metrics like sensitivity, specificity, or AUC.

This document describes a traditional medical device (orthodontic brackets) and its substantial equivalence to a predicate device based on material, design, and intended use, rather than a data-driven performance study. Therefore, the requested information elements related to AI model evaluation are not applicable or present in this document.

To be specific:

A table of acceptance criteria and the reported device performance: Not applicable. The document discusses "technological characteristics" and states "The function and performance of the modified brackets is very similar to the predicate." No quantifiable performance metrics are provided.
Sample size used for the test set and the data provenance: Not applicable. There is no test set in the context of an AI performance evaluation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no ground truth, as this is not an AI diagnostic/prognostic device being evaluated.
Adjudication method: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
If a standalone performance (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

The 510(k) summary focuses on demonstrating that the new orthodontic ceramic brackets are substantially equivalent to previously marketed devices (predicate device K852179) by highlighting minor design changes (dimpled, beveled base, rhomboid and "torque-in-the-base" features, indented walls, optional glass coating, and increased transparency) without changes to the intended use or fundamental scientific technology. All materials used are stated to have been in legally marketed DENTSPLY devices.

Summary

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510(k) SUMMARY

K042178

AUG 3 0 2004

DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, PA 17405-0872

CONTACT:	P. Jeffery Lehn
DATE PREPARED:	August 3, 2004
TRADE OR PROPRIETARY NAME:	ORTHODONTIC CERAMIC BRACKETS
CLASSIFICATION NAME:	Orthodontic Bracket, 872.5470
PREDICATE DEVICES:	Ceramic Orthodontic Bracket, K852179

DESCRIPTION OF DEVICE: The ORTHODONTIC CERAMIC BRACKETS are bonded to teeth to apply pressure to the tooth, transmitted through a flexible orthodontic wire, to alter the tooth position. The dimpled, beveled bracket base includes rhomboid and "torque-in-the-base" features. The modified ceramic, orthodontic brackets have indented walls and are available with or without glass coating in the wire slot. The modified brackets are more transparent than the predicate device.

INTENDED USE: Indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.

TECHNOLOGICAL CHARACTERISTICS: The function and performance of the modified brackets is very similar to the predicate. Minor design changes and a change in transparency are the only modifications made to K852179.

There are no changes in intended use or fundamental scientific technology. All of the materials in the device have been used in legally marketed DENTSPLY devices. We believe that the modified device is substantially equivalent to K852179.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, which is a traditional symbol of medicine.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 3 0 2004

Dentsply International C/O Mr. P Jeffery Lehn Director of Corporate Compliance and Regulatory Affairs Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17404

Re: K042178

Trade/Device Name: Orthodontic Ceramic Brackets Regulation Number: 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: NJM Dated: August 3, 2004 Received: August 11, 2004

Dear Mr. Lehn:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your Because and he 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendments, or to act rood Cosmetic Act (Act) that do not require approval of a premarket the Federal I vou, Drag, and Comments , therefore, market the device, subject to the general approvin uppression (the Act. The general controls provisions of the Act include controls provisions of the ristiation, 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 If your device is classified (boo as a very additional controls. Existing major regulations affecting (1 MA), it may of subject to back and Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in firsher announcements concerning your device in the Federal Register.

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Page 2 - Mr. Lehn

Please be advised that FDA's issuance of a substantial equivalence determination does not I lease be advisod that 12 a determination that your device complies with other requirements Incall that I DX has made a atutes and regulations administered by other Federal agencies. of the Act of ally I oderal buttonents, including, but not limited to: registration 1 ou inust comply with and 07); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 OF R Part 001), abolity systems (QS) regulation (21 CFR Part 820); and if requirements as bet form in the qt 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) I mis letter will anow you to began finding of substantial equivalence of your device to a premiarket notification. - The Pist 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), II you desire specific at 100 for your at (301) 594-4613. Also, please note the regulation prease condact the Other of reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain 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/dsma/dsmamain.html

Sincerely yours,

Susan Runror
Chin-Lin, Ph.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 STATEMENT

510(K) Number (if known): K042178

ORTHODONTIC CERAMIC BRACKETS Device Name:

Indications for Use:

Indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid tecth.

Prescription Use X (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 IF NEEDEL

Concurrence of CDRH, Office of Device Evaluation (ODE)

Swae Kumar

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

510(k) Number:

Regulation Number and Section

§ 872.5470 Orthodontic plastic bracket.

(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.