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

Device Description

The Polycarb 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

This document describes a premarket notification for a dental material called "Polycarb," a thermoplastic resin used for temporary dental prostheses. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting formal acceptance criteria and a detailed study with quantitative performance metrics for the new device.

Therefore, the requested information components related to quantitative performance, such as acceptance criteria tables, sample sizes for test sets, expert consensus, MRMC studies, or standalone algorithm performance, are not applicable to this submission as it primarily addresses the material's properties and equivalence.

Here's an analysis based on the provided text, addressing the applicable points:

A table of acceptance criteria and the reported device performance:
Not applicable. The submission does not define specific quantitative acceptance criteria or report performance metrics in the way a clinical study for a diagnostic or AI device would. The "performance" assessment is based on demonstrating similar design, function, and physical properties to the predicate device.
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
Not applicable. The submission focuses on the material's chemical and physical properties and its substantial equivalence. It does not describe a clinical "test set" in the context of evaluating a device's diagnostic or predictive performance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
Not applicable. There is no mention of a "test set" requiring expert ground truth establishment.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. No test set or expert adjudication process is described.
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. This is a submission for a dental material and does not involve AI assistance or human reader studies.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a dental material, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. The evaluation is based on the material's characteristics and comparison to a predicate, not on generating a medical "ground truth" for diagnostic purposes. The "truth" in this context is the factual chemical and physical properties of the material.
The sample size for the training set:
Not applicable. This submission does not involve a training set as it's not a machine learning or AI device.
How the ground truth for the training set was established:
Not applicable.

Summary based on available information:

The Inovativ Polycarb premarket 510(k) notification (K022030) aims to demonstrate substantial equivalence to an existing predicate device, Flexible Dimensions, LLC "Direct Crown" polycarbonate resin.

Acceptance Criteria (Implied by Substantial Equivalence): The device (Polycarb) must be similar in design, function, physical properties, and intended use to the predicate device. The submission provides a chemical analysis to support these claims. The intended use is for the fabrication of temporary dental prostheses like partial denture clasps, temporary crowns, and bridges.
Study that proves the device meets the acceptance criteria: The study is described as a chemical analysis and a comparison of technological characteristics (design, material characteristics, physical properties, handling characteristics, intended use, and functionality) to the predicate device. The submission asserts that "Both the Polycarb and the predicate device are similar in design, material characteristics, physical properties, handling characteristics, intended use and functionality."

Limitations of the provided text for the requested fields: This 510(k) summary is a regulatory filing for a physical material, not for a diagnostic device, software, or AI system, which typically require detailed clinical performance studies with specific statistical measures, ground truth establishment, and expert involvement. Therefore, many of the requested data points (e.g., sample sizes, expert qualifications, adjudication methods, AI assistance) are not found or applicable in this type of submission.

Summary

{0}------------------------------------------------

AUG 2 8 2002

Inovativ Polycarb Original Premarket 510(K) Notification

K022030

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

This 510(K) summary of safety and effectiveness information is being submitted in accordance 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:	June 10, 2002
9.2 DEVICE IDENTIFICATION
a. Trade/Proprietary Name:	Polycarb

Temporary Crown and Bridge Resin 21 CFR 872.3770

9.3 IDENTIFICATION OF PREDICATE DEVICES

The Polycarb material is a thermoplastic resin used to prefabricate partial denture clasps, temporary crowns and bridges. This material is substantially equivalent to the Flexible Dimensions, LLC, temporary crown and bridge resin. This material is commercially available in the United States.

9.4 DEVICE DESCRIPTION

b. Classification Name:

The Polycarb 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.

{1}------------------------------------------------

Inovativ Polycarb Original Premarket 510(K) Notification

9.5 SUBSTANTIAL EQUIVALENCE

The Polycarb thermoplastic polycarbonate resin is substantially equivalent to the Flexible Dimensions, LLC "Direct Crown" polycarbonate resin. The fundamental characteristics are similar: the Polycarb thermoplastic resin is similar in design, function, physical properties and intended use to the predicate device.

9.6 INDICATIONS FOR USE

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

9.7 TECHNOLOGICAL CHARACTERISTICS

A chemical analysis of the Polycarb is provided within this submission. Both the Polycarb and the predicate device are similar in design, material characteristics, physical properties, handling characteristics, intended use and functionality.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes extending from its head, representing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 8 2002

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

Re: K022030

Trade/Device Name: Poly-Carb Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: June 10, 2002 Received: June 21, 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.

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.

{3}------------------------------------------------

Page 2 - Mr. Bowers

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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!

Tim Keller A. Ulatanaki

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number_________________________________________________________________________________________________________________________________________________________________ K022030

Poly-Carb_ Device Name

Indications for use:

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

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

Prescription Use V (Per 21 CFR 801.109)

Over the counter _____________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Susan Runo

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

510(k) Number: K002030

Page 1 of 1

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.