CORE-IDE

K984037 · Roydent Dental Products, Inc. · EBD · Feb 4, 1999 · Dental

Device Facts

• Record ID: K984037
• Device Name: CORE-IDE
• Applicant: Roydent Dental Products, Inc.
• Product Code: EBD · Dental
• Decision Date: Feb 4, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3310
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

DC-Core / Core-Ide is a self cure micro hybride composite for endodontic post cementations and core build-ups (see enclosed Instruction for Use, MSDS).

Device Story

DC-Core / Core-Ide is a self-cure micro-hybrid composite dental material. It is used by dentists in a clinical setting to build up human teeth that have suffered significant structural loss and for the cementation of endodontic posts. The material is typically applied in conjunction with an adhesive system. It functions as a restorative material to replace missing tooth structure, providing a foundation for subsequent crown or bridge placement. The device is distributed by Roydent and manufactured by P. L. Superior GmbH.

Technological Characteristics

Self-cure micro-hybrid composite dental material. Manufactured in compliance with GMP (21 CFR Part 820) and certified to DIN EN ISO 9003 / DIN EN 46003 and MDD 93/42/EEC.

Indications for Use

Indicated for use by dentists for endodontic post cementation and core build-up in patients requiring restoration of destroyed tooth structure.

Regulatory Classification

Identification

A coating material for resin fillings is a device intended to be applied to the surface of a restorative resin dental filling to attain a smooth, glaze-like finish on the surface of the filling.

Predicate Devices

• BIS-CORE Core Build Up Composite

Submission Summary (Full Text)

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Roydent

## FEB 4 1099

## 10. 510(k) Summary or Statement

**SUMMARY**
K984637

Gentleman:

This submission is pursuent to paragraph 510(k) of the Federal Drug and Cosmetic Act of May, 1976 (as amended) (Title 21 USC). All informations contained herein are to be considered and treated as CONFIDENTIAL COMMERCIAL INFORMATION.

It is the intention of P. L. Superior GmbH to distribute the Roydent DC-Core / Core-Ide cited above manufactured at its facilities at Robert-Bosch-Str. 5, D-25335 Elmshorn, which can be used as Core Build Up material.

P. L. Superior GmbH spezializes in distributing and marketing numerous dental materials and related items manufactured at its facilities at Robert-Bosch-Str. 5, D-25335 Elmshorn, worldwide.

It is P. L. Superior GmbH`s intention to distribute DC-Core / Core-Ide cited herein which is manufactured at its facility located at Robert-Bosch-Straße 5, D-25335 Elmshorn, Germany, employing Good Manufacturing Practices (GMP's) pursuant and according to Title 21 CFR. P. L. Superior GmbH is certified to DIN EN ISO 9003 / DIN EN 46003 and Medical Device Directive (MDD) 93/42/EEC, annex VI.

The DC-Core / Core-Ide may be offered and marketed in the United States by Roydent, in which case P. L. Superior GmbH will maintain control and govern the production and primary packaging. Roydent will maintain the claims, labels, instructions and indications by himself which are consistent with this submission and final FDA 510(k) clearance to market by P. L. Superior GmbH.

The chemistry of DC-Core / Core-Ide P. L. Superior GmbH distributes for Roydent is commonly used in current dental materials.

The purpose of this material for use by the dentist is to clinically build up human teeth (restauration in the case of mostly destroyed tooth structure). The material is in general placed against an applied adhesive system.

The chemical composition and use of DC-Core / Core-Ide is substantially equivalent to "BIS-CORE Core Build Up Composite", a product manufactured and marketed by BISCO Dental Products, ITASCA, ILLINOIS USA.

Respectfully submitted

Jürgen Engelbrecht, Ph. D.
Regulatory Compliance Officer

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three parallel lines forming its wings and body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 4 1999

Mr. Don Leroy President ROYDENT Dental Products 1010 West Hamlin Road Rochester Hills, Michigan 48309

K984037 Re : Trade Name: Core-Ide Requlatory Class: II Product Code: EBD Dated: September 1, 1998 November 12, 1998 Received:

Dear Mr. Leroy:

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, 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Leroy

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 requlation 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,

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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## 9. Statement of Indications for Use

510(k) Number (if known): -

Device Name: DC-Core / Core-Ide

Indications for Use:

DC-Core / Core-Ide is a self cure micro hybride composite for endodontic post cementations and core build-ups (see enclosed Instruction for Use, MSDS).

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use:

Susan Rumper

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

Over-The-Counter Use: