GCUC-505

K091388 · GC America, Inc. · EBF · Jul 22, 2009 · Dental

Device Facts

• Record ID: K091388
• Device Name: GCUC-505
• Applicant: GC America, Inc.
• Product Code: EBF · Dental
• Decision Date: Jul 22, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 Splinting mobile teeth Additions to composite restorations

Device Story

MI Fil (GCUC-505) is a light-cured, nano-filled, radiopaque composite resin; supplied in a syringe with a needle tip for precise application. Used by dental professionals in clinical settings for restorative dentistry. Material is applied to prepared tooth cavities or surfaces and cured using a dental light source. Functions as a restorative filling material, liner, base, or sealant. Benefits patients by providing aesthetic, durable tooth-colored restorations and addressing hypersensitivity or tooth mobility.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use compared to predicate devices.

Technological Characteristics

Light-cured, nano-filled, radiopaque composite resin. Available in 17 shades. Delivered via syringe with needle tip. Flowable consistency. Class II device (21 CFR 872.3690).

Indications for Use

Indicated for dental patients requiring restoration of Class I-V cavities, root surface caries, deciduous teeth, tunnel-shaped cavities, hypersensitive areas, cavity undercuts, sealants, splinting of mobile teeth, and additions to existing composite restorations.

Regulatory Classification

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.

Predicate Devices

• GRADIA DIRECT LoFlo (K042348)
• GDLS-200 (Kalore) (K082434)
• TETRIC EVOCERAM (K042819)

Submission Summary (Full Text)

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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: | [phone] |
| Fax: | [phone] |

Date Prepared: May 4, 2009

### Device Name:

t

| 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:

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.

### 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 [phone] or [phone] 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

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

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

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