K Number
K070319
Device Name
GC FUJI IX GP EXTRA
Manufacturer
Date Cleared
2007-02-26

(24 days)

Product Code
Regulation Number
872.3275
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Class I and II restorations in deciduous teeth Non-load bearing Class I and II restorations in permanent teeth Immediate restorative and base material for heavy stress situation in Class I and II cavities using sandwich laminate technique Class V and root surface restorations Core build up
Device Description
Not Found
More Information

Not Found

Not Found

No
The provided text does not contain any mention of AI, ML, deep learning, or related concepts, and the device description is not available.

Yes
The device is used for restorations in teeth, which is a therapeutic intervention for dental issues.

No
The provided text describes the intended use of a dental restorative material, which is a treatment device, not a diagnostic one.

No

The provided text describes the intended use of a dental restorative material, which is a physical substance, not a software-only device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended uses listed are all related to restoring teeth. This involves direct application and manipulation within the patient's mouth.
  • IVD Definition: In vitro diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. The intended uses described here do not involve analyzing specimens outside the body.

The device appears to be a dental restorative material, which is a medical device but not an IVD.

N/A

Intended Use / Indications for Use

Class I and II restorations in deciduous teeth Non-load bearing Class I and II restorations in permanent teeth Immediate restorative and base material for heavy stress situation in Class I and II cavities using sandwich laminate technique Class V and root surface restorations Core build up

Product codes

EMA

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

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Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Terry L. Joritz-Lyons Director - Regulatory Affairs and Ouality Assurance GC America, Incorporated 3737 West 127m Street Alsip, Illinois 60803

FEB 2 6 2007

Re: K070319

Trade/Device Name: GC Fuji IX GP EXTRA Regulation Number: 21 CFR 872.3275(b) Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: January 29, 2007 Received: February 05, 2007

Dear Ms. Joritz-Lyons:

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.

1

Page 2 - Ms. Terry L. Joritz-Lyons

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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Susan Funne
Chiu S. Lin, PhD
Director
Division of Anesthesiology, General Hospital,
Infection Control and Dental Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

2

Indications for Use

KO +6319 510(k) Number (if known)

Device Name: Fuji IX GP EXTRA

Indications for Use:

Class I and II restorations in deciduous teeth Non-load bearing Class I and II restorations in permanent teeth Immediate restorative and base material for heavy stress situation in Class I and II cavities using sandwich laminate technique Class V and root surface restorations Core build up

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)

Susy Burns

620319

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