Restoration of Class I, II, III, IV, V cavities Restoration of root surface caries Restorations in deciduous teeth Filling tunnel shaped cavities Sealing hypersensitive areas Liner/base/filling in cavity undercuts Sealant Splinting mobile teeth Additions to composite restorations

Device Description

MI Fil (GCUC-505) is a light-cured nano-filled radiopaque composite resin filled in a syringe topped with a needle tip. The device is a flowable composite resin of normal consistency. The material is available in 17 shades.

AI/ML Overview

The provided text (K091388) is a 510(k) summary for a dental device called "MI Fil (GCUC-505)". This document is a regulatory submission for a Class II medical device, specifically a tooth shade resin material. It focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving performance against specific acceptance criteria through a clinical study.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable or cannot be extracted from this type of regulatory document.

Here's an breakdown of what can and cannot be answered based on the provided text:

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

Not Applicable/Not Provided: This document does not present specific quantitative acceptance criteria or detailed performance results from a study designed to meet such criteria. 510(k) submissions primarily focus on demonstrating substantial equivalence through comparison of technological characteristics and indications for use with predicate devices, often relying on non-clinical (e.g., bench) tests rather than clinical performance studies with acceptance criteria in the sense typically used for AI/diagnostic devices.

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

Not Applicable/Not Provided: The document does not describe a "test set" in the context of a clinical performance study. There's no information about sample size, data provenance, or study design.

3. 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/Not Provided: No experts were mentioned or used for establishing ground truth for a test set, as this is not a clinical performance study involving diagnostic accuracy.

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

Not Applicable/Not Provided: There is no "test set" or adjudication method mentioned.

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/Not Provided: This device is a dental composite resin, not an AI or diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is entirely irrelevant and was not performed.

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

Not Applicable/Not Provided: This device is a physical material, not an algorithm. Therefore, a standalone algorithm performance study was not conducted.

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

Not Applicable/Not Provided: No ground truth in this context was established, as this is not a diagnostic device.

8. The sample size for the training set

Not Applicable/Not Provided: There is no "training set" for this device.

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

Not Applicable/Not Provided: There is no "training set" or ground truth for it.

Summary of Device and Substantial Equivalence (from the text):

Device Name: MI Fil (GCUC-505)
Description: A light-cured nano-filled radiopaque composite resin, flowable, available in 17 shades.
Indications for Use: Restoration of Class I, II, III, IV, V cavities; restoration of root surface caries; restorations in deciduous teeth; filling tunnel shaped cavities; sealing hypersensitive areas; liner/base/filling in cavity undercuts; sealant; fixing loose teeth; additions to composite restorations.
Predicate Devices:
- GC America Inc. GRADIA DIRECT LoFlo (K042348)
- GC America Inc. GDLS-200 (K082434)
- Ivoclar Vivadent, Inc. TETRIC EVOCERAM (K042819)
Substantial Equivalence Claim: The applicant device is substantially equivalent to the predicate devices in its intended use, as they are all composite resins used for restorations of teeth, filling material, and sealant.

Conclusion based on the provided document:

The provided 510(k) summary for MI Fil (GCUC-505) is a regulatory filing demonstrating substantial equivalence to legally marketed predicate devices. It does not contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria in the manner requested for a diagnostic or AI-driven device. The evaluation of this device would typically involve non-clinical testing (e.g., mechanical properties, biocompatibility) to show it performs similarly to predicate devices, but such details are not explicitly provided in this summary.

Summary

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K691388

Section 5 - Summary of 510(k)

JUL 2 2 2009

510(k) Summary for MI Fil (GCUC-505)

Submitter Information:

GC AMERICA INC. 3737 W. 127th Street Alsip, IL 60803

Contact Person:	Mark Heiss, D.D.S.
Phone:	(708) 897-4042
Fax:	(708) 897-4031

Date Prepared: May 4, 2009

Device Name:

Proprietary Name:	MI Fil (GCUC-505)
Classification Name:	Tooth Shade Resin Material
Device Classification:	Class II, 872.23690
Produce Code:	EBF

Predicate Devices:

Company	Device	K Number	Date Cleared
GC America Inc.	GRADIA DIRECT LoFlo	K042348	01/30/2003
GC America Inc.	GDLS-200 (Kalore)	K082434	11/14/2008
Ivoclar Vivadent, Inc.	TETRIC EVOCERAM	K042819	11/09/2004

Description of Device:

Indications for use:

Restoration of Class 1, 11, 111, 1V, V cavities Restoration of root surface caries Restorations in deciduous teeth Filling tunnel shaped cavities Sealing hypersensitive areas Liner/base/filling in cavity undercuts Sealant Fixing loose teeth Additions to composite restorations

Decription of Safety and Substantial Equivalence:

The applicant device is substantially equivalent to the predicate devices in its intended use. They are all composite resins and are used for the restorations of both anterior teeth. They are also used as a filling material and sealant.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling the image of an eagle. The eagle is stylized with three distinct wing-like shapes, and it is facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 222009

Mark Heiss, D. D. S. Director of New Business Development and Regulatory Affairs GC America, Incorporated 3737 West 127th Street Alsip, Illinois 60803

Re: K091388

Trade/Device Name: MI Fil (GCUC-505) Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF, EBC, LBH Dated: May 4, 2009 Received: May 11, 2009

Dear Dr. Heiss:

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 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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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/cdrl/mdr/ 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 free free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
Susan Runne,

Susan Runner, D.D.S., M.A. Acting 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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Section 6 - Indications for Use Statement

Indications for Use

510(k) Number (if known): K091385

Device Name: MI Fil (GCUC-505)

Indications for Use:

Intended use

Prescription Use
(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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kai Mulvey for WSR

(Division Sign-Off)

Division of Anesthesiology, General Hospital -Infection Control, Dental Devices

510(k) Number: K091388

Page 6.1 of 6.1

Regulation Number and Section

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.