ALPHA-CORE DC

K070191 · Dental Technologies, Inc. · EBF · Mar 7, 2007 · Dental

Device Facts

• Record ID: K070191
• Device Name: ALPHA-CORE DC
• Applicant: Dental Technologies, Inc.
• Product Code: EBF · Dental
• Decision Date: Mar 7, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Core buildups. Cementation of pins and posts when used with suitable dentin adhesive.

Device Story

Alpha-Core DC is a dental resin material used for core buildups and cementation of pins and posts. It is applied by dental professionals in a clinical setting. The material functions as a restorative agent to support dental structures. It requires use with a suitable dentin adhesive for post/pin cementation. The device aids in the reconstruction of damaged teeth, providing a foundation for subsequent crown or bridge restorations.

Clinical Evidence

Bench testing only.

Technological Characteristics

Dual-cure (DC) resin-based dental material. Formulated for core buildup and cementation applications. Class II medical device.

Indications for Use

Indicated for core buildup procedures and the cementation of pins and posts in dental patients requiring restorative treatment.

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 logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

MAR 0 7 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Janine Rauhut Quality Assurance & Regulatory Affairs Manager Dental Technologies, Incorporated 6901 North Hamlin Avenue Lincolnwood, Illinois 60712

Re: K070191

Trade/Device Name: Alpha-Core DC Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: January 10, 2007 Received: January 22, 2007

Dear Ms. Rauhut:

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.

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## Page 2 - Ms. Janine Rauhut

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Syette Y. Michael DMD.

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

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Image /page/2/Picture/0 description: The image shows the logo for Dental Technologies. The logo consists of a geometric shape on the left and the words "DENTAL TECHNOLOGIES" on the right. The geometric shape is made up of small squares, some of which are filled in with black and some of which are white.

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## Indications for Use

110 7091 510(k) Number (if known):

Device Name: Alpha-Core DC

Indications for use:

- Core buildups. ■
- . Cementation of pins and posts when used with suitable dentin adhesive.

ISO 9001

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE),

| DENTAL TECHNOLOGIES, INC.<br>6901 N. HAMLIN AVENUE<br>LINCOLNWOOD, ILLINOIS 60712 USA | Page 14 of 157 |
|---------------------------------------------------------------------------------------|----------------|
| 1.800.835.0885 TOLL FREE [US/CANADA]<br>1.847.677.5500 PHONE<br>1.847.677.5502 FAX | |

Susan Russpar

K070191