A dental matrix band is a non-sterile single use disposable device intended to be place around a tooth to keep filling material from bonding onto the other tooth. Matrix bands are used to form missing walls of prepared teeth. They shape and confine restorative materials to areas prepared to receive restorations.

Device Description

The Dental Matrix Band is made of medical grade stainless steel with a tin coating. The dental matrix bands are offered non-sterile single use.

AI/ML Overview

This document describes a 510(k) premarket notification for a Dental Matrix Band, a Class I medical device. The information provided is primarily focused on establishing substantial equivalence to a predicate device rather than presenting detailed performance studies with acceptance criteria in the way one would for a novel, higher-risk device or an AI/ML powered medical device.

Therefore, the requested AI/ML-specific information (expert consensus, training/test set details, MRMC studies, standalone performance, etc.) is not applicable to this submission. This is a conventional medical device that relies on material testing and comparison to an existing product.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Intended Use	The device is intended to be placed around a tooth to keep filling material from bonding onto the other tooth. It is used to form missing walls of prepared teeth, shaping and confining restorative materials.
Size and Configuration	Substantially equivalent to Dentsply, Inc., Dental Matrix Band. Specific sizes and configurations are not detailed but are implied to match the predicate.
Base Material	Made of medical grade stainless steel with a tin coating. Considered substantially equivalent to Dentsply, Inc., Dental Matrix Band.
Biological Evaluation (Biocompatibility)	Materials were tested per ISO 10993 Biological Evaluation for Medical Devices for a "surface indicating, skin, limited exposure device".

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

Not applicable. This is not a study involving human data or a "test set" in the context of an AI/ML algorithm. The "testing" referred to is materials testing for biocompatibility.

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

Not applicable. Ground truth for a test set (in an AI/ML context) is not relevant for this device.

4. Adjudication Method 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

No such study was conducted or is relevant for this device.

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

Not applicable. This is not an AI/ML device.

7. The Type of Ground Truth Used

Not applicable in the context of AI/ML. The "ground truth" for this device's performance is established by its material properties meeting ISO 10993 standards and its physical characteristics (intended use, size, configuration, material) being comparable to a legally marketed predicate device.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

Study that Proves the Device Meets the Acceptance Criteria:

The "study" referenced for this device is a "Summary of Testing" which states:

Materials were tested per ISO 10993 Biological Evaluation for Medical Devices for a surface indicating, skin, limited exposure device.

This indicates that biocompatibility testing was performed according to internationally recognized standards for medical devices. The specific results of this testing (e.g., passing specific cytotoxicity, sensitization, or irritation tests) are not detailed in this summary but are implicit in the claim of testing per ISO 10993.

The primary proof of the device meeting its acceptance criteria (beyond biocompatibility) is its substantial equivalence to a predicate device, the Dentsply, Inc., Dental Matrix Band. The argument for substantial equivalence is based on the new device sharing the same:

Intended use
Size and configuration
Base material

The FDA's decision to clear the device (K071858) confirms that they found sufficient evidence of substantial equivalence to the predicate device, implying that the provided testing and comparative analysis were deemed adequate.

Summary

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Attachment 4

9.0 SUMMARY OF SAFETY AND EFFECTIVENESS

DENTAL MATRIX BAND

AUG 3 1 2007

Manufacturer:	Fly Cast Technologies, Inc.30647 Countryside DriveLibertyville, Illinois 60048
Regulatory Affairs Contact:	Michele VovolkaP.O. Box 848Grayslake, Illinois 60030
Telephone:	(847) 856-0355
Date Summary Prepared:	August 25, 2007
Product Trade Name:	Dental Matrix Band
Common Name:	Dental Matrix Band
Classification:	Class I

Predicate Devices:

Description: The Dental Matrix Band is made of medical grade stainless steel with a tin coating. The dental matrix bands are offered non-sterile single use.

A dental matrix band is a non-sterile single use disposable device intended to be Intended Use: place around a tooth to keep filling material from bonding onto the other tooth. Matrix bands are used to form missing walls of prepared teeth. They shape and confine restorative materials to areas prepared to receive restorations.

Substantial Equivalence: The Dental Matrix Band is substantially equivalent to the Dentsply, Inc., Dental Matrix Band in that they provide the following characteristics:

Intended use
Size and configuration
Base material

Summary of Testing: Materials were tested per ISO 10993 Biological Evaluation for Medical Devices for a surface indicating, skin, limited exposure device

CONFIDENTIAL

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Fly Cast Technologies, Incorporated C/O Ms. Michele H. Vovolka Regulatory Consultant Vantage Consulting International, Limited PO Box 848 Grayslake, Illinois 60030

AUG 3 1 2007

Re: K071858

Trade/Device Name: Dental Matrix Band Regulation Number: 21 CFR 872.4565 Regulation Name: Dental Hand Instrument Regulatory Class: I Product Code: DZN Dated: June 21, 2007 Received: July 5, 2007

Dear Ms. Vovolka:

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.

Image /page/1/Picture/10 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

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Page 2 - Ms. Vovolka

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 (OS) 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.

Sineerely yours,

Suste Y. Mohammd,

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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Attachment 3

K071858

Page 1 of 1

510(k) Number (if known):

Device Name: Dental Matrix Band

Indications For Use:

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over -The-Counter Use (Part 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)

Suvek Kumar

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

510(k) Number: K071858

CONFIDENTIAL

Regulation Number and Section

§ 872.4565 Dental hand instrument.

(a)
Identification. A dental hand instrument is a hand-held device intended to perform various tasks in general dentistry and oral surgery procedures. The device includes the operative burnisher, operative amalgam carrier, operative dental amalgam carver, surgical bone chisel, operative amalgam and foil condenser, endodontic curette, operative curette, periodontic curette, surgical curette, dental surgical elevator, operative dental excavator, operative explorer surgical bone file, operative margin finishing file, periodontic file, periodontic probe, surgical rongeur forceps, surgical tooth extractor forceps, surgical hemostat, periodontic hoe, operative matrix contouring instrument, operative cutting instrument, operative margin finishing periodontic knife, periodontic marker, operative pliers, endodontic root canal plugger, endodontic root canal preparer, surgical biopsy punch, endodontic pulp canal reamer, crown remover, periodontic scaler, collar and crown scissors, endodontic pulp canal filling material spreader, surgical osteotome chisel, endodontic broach, dental wax carver, endodontic pulp canal file, hand instrument for calculus removal, dental depth gauge instrument, plastic dental filling instrument, dental instrument handle, surgical tissue scissors, mouth mirror, orthodontic band driver, orthodontic band pusher, orthodontic band setter, orthodontic bracket aligner, orthodontic pliers, orthodontic ligature tucking instrument, forceps, for articulation paper, forceps for dental dressing, dental matrix band, matrix retainer, dental retractor, dental retractor accessories, periodontic or endodontic irrigating syringe, and restorative or impression material syringe.(b)
Classification. Class I (general controls). If the device is made of the same materials that were used in the device before May 28, 1976, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.