DC-CORE

K984097 · S & C Polymer GmbH · EBF · Feb 9, 1999 · Dental

Device Facts

• Record ID: K984097
• Device Name: DC-CORE
• Applicant: S & C Polymer GmbH
• Product Code: EBF · Dental
• Decision Date: Feb 9, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

DC-CORE is a dual cured micro hybride composite for endodontic post cementations and core build-ups.

Device Story

DC-CORE is a dual-cured micro-hybrid composite dental material. It is used by dentists in a clinical setting to restore destroyed tooth structure by performing core build-ups and cementing endodontic posts. The material is applied against an adhesive system. It functions as a restorative dental material to rebuild the tooth structure, providing a foundation for subsequent crown or bridge placement. The device is manufactured by S & C Polymer GmbH and marketed for professional dental use.

Clinical Evidence

Bench testing only.

Technological Characteristics

Dual-cured micro-hybrid composite. Manufactured under DIN EN ISO 9001 / DIN EN 46001 and MDD 93/42/EEC standards. No specific material specs or software components described.

Indications for Use

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

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.

Predicate Devices

• BIS-CORE Core Build Up Composite (BISCO Dental Products)

Submission Summary (Full Text)

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## 10. 510(k) Summary or Statement

## SUMMARY

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 S & C Polymer GmbH to manufacture the DC-Core cited above which can be used as Core Build Up material.

S & C Polymer spezializes in manufacturing, distributing and marketing numerous dental materials and related items worldwide.

It is S & C Polymer GmbH`s intention to manufacture DC-Core herein at its facility located at Robert-Bosch-Straße 5, D-25335 Elmshorn (formerly Offenauer Weg 19, D-25335 Bokholt-Hanredder), Germany, employing Good Manufacturing Practices (GMP's) pursuant and according to Title 21 CFR. S & C Polymer GmbH is certified to DIN EN ISO 9001 / DIN EN 46001 and Medical Device Directive (MDD) 93/42/EEC, annex II.

DC-Core may be offered and marketed in the United States by Henry Schein Inc. and/or Pharmex, in which case S & C Polymer will maintain control and govern the production and primary packaging. The claims, labels, instructions and indications consistent with this submission and final FDA 510(k) clearance to market will be controlled and governed by Henry Schein Inc. or Pharmex.

The chemistry of DC-Core S & C Polymer GmbH manufactures for Henry Schein Inc. and Pharmex 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 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 9 1999

Jürgen Ebgelbrecht, Ph.D. President S & C Polymer Silicon- und Composite-Spezialitäten GmbH Robert-Bosch-StraBe 5 D-25335 Elmshorn GERMANY

Re : K984097 Trade Name: DC-CORE Requlatory Class: II Product Code: EBF Dated: January 15, 1999 Received: January 25, 1999

Dear Dr. Engelbrecht:

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 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). 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 reqistration, 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਹੈ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 In addition, FDA may publish further announcements action. 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 – Dr. Engelbrecht

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" (21CFR 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/dsma/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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K984097 510(k) NUMBER (IF KNOWN):

DC-CORE DEVICE NAME:

INDICATIONS FOR USE:

ﺎ ﺑﮩﺖ ﻣ

DC-CORE is a dual cured micro hybride composite for endodontic post cementations and core build-ups (see enclosed page 6 of our actual 510(k) submission !).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ﯾﺎ (Per 21 CFR 801.109) OR

Over-The-Counter-Use (Optional Format 1-2-96)

Susan Varga

(Division Sign-Off) Division of Dents Infection Control, and General ting Delice 510(k) Number