CLEARFIL DC CEMENT

K980232 · Kuraray Company, Ltd. · EMA · Feb 24, 1998 · Dental

Device Facts

• Record ID: K980232
• Device Name: CLEARFIL DC CEMENT
• Applicant: Kuraray Company, Ltd.
• Product Code: EMA · Dental
• Decision Date: Feb 24, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

1) Porcelain inlay cementation 2) Composite resin inlay cementation 3) Jacket crown cementation with porcelain or composite resin

Device Story

Clearfil DC Cement is a dental restorative material used for the permanent cementation of porcelain and composite resin inlays and jacket crowns. It is intended for professional use by dentists in a clinical setting. The device functions as a luting agent to bond dental restorations to prepared tooth structures. It is applied by the clinician to the restoration or tooth surface to ensure secure fixation and marginal integrity. The cementation process aids in the restoration of tooth function and aesthetics for patients requiring prosthetic dental work.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dual-cure (DC) resin-based dental cement. Formulated for use with porcelain and composite resin restorative materials. Supplied as a multi-component system for mixing and application. No specific ASTM standards or software components described.

Indications for Use

Indicated for the cementation of porcelain inlays, composite resin inlays, and jacket crowns made of porcelain or composite resin.

Regulatory Classification

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. 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.

Submission Summary (Full Text)

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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 in a circular arrangement around a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Hiro Yonekura Vice President Kuraray Company, Ltd. C/O Kuraray America Incorporated 200 Park Avenue 30th FI. Metlife Building New York, New York 10166-3098

FEB 2 4 1998

Re : K980232 Clearfil DC Cement Trade Name: Requlatory Class: II Product Code: EMA Dated: January 22, 1998 Received: January 22, 1998

Dear Mr. Yonekura:

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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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 In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does

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Page 2 - Mr. Yonekura

not affect any obligation you might have under sections 531 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 requlation (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,

Patricia Cucurella ffor

Timothy A. Ulatowski 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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510(k) Number (if known): K980232
Device Name: CLEARFIL DC CEMENT

## Indications for Use

- 1) Porcelain inlay cementation
- 2) Composite resin inlay cementation
- 3) Jacket crown cementation with porcelain or composite resin

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OR

Coneurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runoer

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K984232

Prescription Use " (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)