The Acrylic is intended for the fabrication of temporary dental prostheses like temporary crowns and bridges, flippers, orthodontic retainers, and occlusal guards using the Inovativ, LLC Acrylic resin.

Device Description

The Acrylic material is a thermoplastic resin that is used to fabricate dental prostheses. The resin is used in an injection molding or pressing device to fabricate the prostheses.

AI/ML Overview

The provided text is a 510(K) summary for the "Inovativ Acrylic" device. This document is a premarket notification for a medical device which aims to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. This type of submission generally relies on demonstrating similar design, materials, technological characteristics, and intended use, rather than presenting a study with specific acceptance criteria and performance metrics in the way that, for example, an AI diagnostic device would.

Therefore, many of the requested categories for acceptance criteria and study details are not applicable to this type of submission.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not present in the provided text. The document asserts "substantial equivalence" based on similar fundamental characteristics and physical properties to a predicate device, rather than defining specific performance acceptance criteria and reporting against them.

2. Sample size used for the test set and the data provenance:

This information is not present. No specific "test set" or clinical study data is described. The submission is based on comparison to a predicate device.

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

This information is not present. No ground truth establishment by experts is described as this is not a diagnostic device and no clinical data is presented in this summary.

4. Adjudication method for the test set:

This information is not present.

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:

This is not applicable. The device (Inovativ Acrylic) is a thermoplastic resin for dental prostheses, not an AI diagnostic tool. No MRMC study or AI assistance is mentioned.

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

This is not applicable. The device is not an algorithm.

7. The type of ground truth used:

This information is not present. No ground truth for performance is established in the document. Substantial equivalence is based on physical and chemical properties as compared to a predicate device.

8. The sample size for the training set:

This information is not present. The device is not an AI algorithm and does not have a training set.

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

This information is not present.

Summary of what is present:

Device Name: Acrylic
Manufacturer: Inovativ, LLC.
Predicate Device: Health-Dent International, Inc. "Dent-Temp Acrylic"
Basis for Equivalence: Similar in design, function, physical properties, chemical composition, handling characteristics, and intended use to the predicate device.
Intended Use: Fabrication of temporary dental prostheses like partial denture clasps, temporary crowns, and bridges (later expanded to include flippers, orthodontic retainers, and occlusal guards).
Regulatory Classification: Class II, Temporary Crown and Bridge Resin (21 CFR 872.3770).

This document serves to demonstrate substantial equivalence to an existing legally marketed device, meaning it has the same intended use and the same technological characteristics as the predicate device, or if it has different technological characteristics, the information submitted demonstrates that the device is as safe and effective as the legally marketed device and does not raise different questions of safety and effectiveness. It does not typically involve the type of performance studies with acceptance criteria and ground truth typical of novel diagnostic devices or AI applications.

Summary

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MAR 2 1 2003

INOVATIV, LLC.

KO24282

1155 Twin Hills Drive Jefferson, OR. 97352 Phone: 503-585-4362 Fax: 503-585-1188

510 (K) Summary

Submitter Name:

Submitter Address:

Submitter Telephone: Submitter Facsimile:

Contact Person:

Date Summary Prepared:

Inovativ, LLC.

1155 Twin Hills Drive Jefferson, OR 97352

(503)585-4362 (503)585-1188

Bob Bowers Chief Operating Officer

November 18, 2002

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Iı ovativ Acrylic Original Premarket 510(K) Notification

SECTION 9: 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(K) summary of safety and effectiveness information is being submitted in a :cordance with the requirements of SMDA 1990 and 21 CFR.807.92.

9 1 SUBMITTER INFORMATION

a. Company Name:	Inovativ, LLC.
b. Company Address:	1155 Twin Hills DriveJefferson, OR 97352
c. Company Telephone:Company Facsimile:	(503)585-4362(503)585-1188
d. Contact Person:	Bob BowersChief Operating Officer
e. Date Summary Prepared:	November 18, 2002
9.2 DEVICE IDENTIFICATION
a. Trade/Proprietary Name:	Acrylic

b. Classification Name:

Temporary Crown and Bridge Resin 21 CFR 872.3770

5.3 IDI:NTIFICATION OF PREDICATE DEVICES

The Acrylic material is a thermoplastic resin used to prefabricate partial denture clasps, temporary crowns and bridges. This material is substantially equivalent to the Health-Dent International, Inc. "Dent-Temp Acrylic". This material is commercially available in the United States.

1.4 DEVICE DESCRIPTION

The Acrylic material is a thermoplastic resin that is used to fabricate dental prostheses. The resin is used in an injection molding or pressing device to fabricate the prostheses.

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I 10vativ Acrylic ( )riginal Premarket 510(K) Notification

5.5 SUBSTANTIAL EQUIVALENCE

The Acrylic thermoplastic Acrylic resin is substantially equivalent to the Health-Dent International, Inc. "Dent-Temp Acrylic resin. The fundamental characteristics are similar: the Acrylic thermoplastic resin is similar in design, function, physical properties and intended use to the predicate device.

1.6 INDICATIONS FOR USE

The Acrylic is intended for the fabrication of temporary dental prostheses like partial denture clasps, temporary crowns, and bridges using the Inovativ, LLC Acrylic resin.

9.7 TECHNOLOGICAL CHARACTERISTICS

Chemical composition and properties of the Acrylic is provided within this submission. Both the Acrylic and the predicate device are similar in design, material characteristics, physical properties, handling characteristics, intended use and functionality.

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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 1 2003

Mr. Robert Bowers Chief Operating Officer Inovativ. LLC 1155 Twin Hills Drive Jefferson, Oregon 97352

Re: K024282

Trade/Device Name: Acrylic Regulation Number: 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: November 18, 2002 Received: December 23, 2002

Dear Mr. Bowers:

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 - Mr. Bowers

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 (301) 594-4613. 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/dsma/dsmamain.html

Sincerely yours,

Susan Runner, DDS, M Interim 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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Inovativ Acrylic Original Premarket 510(K) Notification

SECTION 8. 510(K) STATEMENT OF INDICATIONS FOR USE

The 501(K) statement of indications for use for this device is being submitted in accordance with the requirements or 21 CFR 807.87.

8.1 STATEMENT OF INDICATIONS FOR USE.

Indications for Use

510(k) Number

Device Name

Indications for use:

Do not write below this line - Continue on another page if needed

l'rescription Use (Per 21 CFR 801.109)

Over the counter

(Optional Format 1-2-96)

Kein Muluy for A CR
8-1

ision of Anesthesiology, General Hospital. Infection Control. De

510(k) Number. K024282

Regulation Number and Section

§ 872.3770 Temporary crown and bridge resin.

(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.