GC FUJI FIL LC

• K Number: K051427
• Device Name: GC FUJI FIL LC
• Manufacturer: GC AMERICA, INC.
• Date Cleared: 2005-08-22 ( 82 days)
• Product Code: EMA
• Regulation Number: 872.3275
• Type: Traditional
• Panel: Dental
• Reference & Predicate Devices: N/A
• Predicate For: K123265 , K130223 , K152652 , K172382

Intended Use

This product is a radiopaque light-cured reinforced glass ionomer restorative for use in the following recommended indications:

1. Class III and V restorations, particularly for cervical erosions and root surface caries.
2. Restoration of primary teeth
3. Core Build-up
4. Cases where radiopacity is required
5. As a base or a liner.

Device Description

GC Fuji Fil LC is a radiopaque light-cured reinforced glass ionomer restorative.

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter for a dental cement (GC Fuji Fil LC), indicating it has been found substantially equivalent to a legally marketed predicate device.

The document includes:

• Trade/Device Name: GC Fuji Fil LC
• Regulation Number: 21 CFR 872.3275
• Regulation Name: Dental Cement
• Regulatory Class: II
• Product Code: EMA
• Indications for Use:
  1. Class III and V restorations, particularly for cervical erosions and root surface caries.
  2. Restoration of primary teeth
  3. Core Build-up
  4. Cases where radiopacity is required
  5. As a base or a liner.

However, it does not contain details regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for any test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication method.
5. Multi-reader, multi-case (MRMC) comparative effectiveness study.
6. Standalone (algorithm only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This kind of detailed study information is typically found in the 510(k) submission summary or the actual study reports, which are not part of this FDA clearance letter.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA".

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 2 2005

Mr. Terry L. Joritz Director, Customer Care Group GC America, Incorporated 3737 West 127th Street Alsip, Illinois 60803

Re: K051427

Trade/Device Name: GC Fuji Fil LC Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: May 31, 2005 Received: June 6, 2005

Dear Mr. Joritz:

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 vour 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. Joritz

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Susan Runno
f Stacie Lin, Ph.D.

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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Indications for Use

510(k) Number (if known): _K051427

Device Name: GC Fuji Fil LC

Indications for Use:

This product is a radiopaque light-cured reinforced glass ionomer restorative for use in the following recommended indications:

• 1. Class III and V restorations, particularly for cervical erosions and root surface caries.
• 2. Restoration of primary teeth
• 3. Core Build-up
• 4. Cases where radiopacity is required
• 5. As a base or a liner.

Prescription Use
(21 CFR Part 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR Part 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suzer Russo

(Division S
Divi-y General Hospital,
Control Uercal Devices

i(k) Number kas7wa7

Page 1 of 1

Regulation Number and Section

§ 872.3275 Dental cement.

(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.