SOLIDEX

K972292 · Shofu Dental Corp. · EBF · Oct 29, 1997 · Dental

Device Facts

• Record ID: K972292
• Device Name: SOLIDEX
• Applicant: Shofu Dental Corp.
• Product Code: EBF · Dental
• Decision Date: Oct 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Solidex is a light cured, hard crown and bridge composite. It is suitable for use in the construction of crowns and bridges, telescopic and cone crowns, attachment work, implant restoration, facings, jacket crowns, inlays and onlays, long-term provisionals, and veneers. It is universal product suitable for all classes of reconstructions, provided it is supported by adequated by working framework.

Device Story

Solidex is a light-cured composite resin used by dental professionals for restorative dentistry. It serves as a material for constructing crowns, bridges, inlays, onlays, and veneers. The material is applied to a supporting framework and cured using a light source to achieve hardness. It is intended for clinical use in dental offices to restore tooth structure or replace missing teeth, providing a durable, aesthetic solution for various dental reconstructions.

Clinical Evidence

Bench testing only.

Technological Characteristics

Light-cured composite resin material for dental crown and bridge construction. Requires external light source for polymerization. Universal application for various dental reconstructions.

Indications for Use

Indicated for dental patients requiring crown and bridge reconstructions, including telescopic/cone crowns, attachment work, implant restorations, facings, jacket crowns, inlays, onlays, veneers, and long-term provisionals, provided adequate framework support exists.

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES ----------------------------------------------------------------------------------------------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized image of three human profiles facing right. The profiles are stacked vertically, with the top profile being the most prominent and the bottom profile being the least prominent. The seal is black and white.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Hideaki Kumazawa ·Shofu Dental Corporation 4025 Bohannon Drive Menlo Park, California 94025

OCT 2 9 1997

K972292 Re: Trade Name: Solidex Regulatory Class: II Product Code: EBF Dated: August 15, 1997 Received: August 27; 1997 --

Dear Mr. Kumazawa:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸੀ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Kumazawa

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

K. Allworth

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

. Enclosure

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## Indication for Use

Solidex is a light cured, hard crown and bridge composite. It is suitable for use in the construction of crowns and bridges, telescopic and cone crowns, attachment work, implant restoration, facings, jacket crowns, inlays and onlays, long-term provisionals, and veneers. It is universal product suitable for all classes of reconstructions, provided it is supported by adequated by working framework.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sueen tum

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number ka 7030

Prescription Use S (Per 21CFR§801 (109) OR

Over-The-Counter Use No