BRECOMP

K052779 · Bredent-Products For the Dental Technician Laborat · EBF · Dec 20, 2005 · Dental

Device Facts

• Record ID: K052779
• Device Name: BRECOMP
• Applicant: Bredent-Products For the Dental Technician Laborat
• Product Code: EBF · Dental
• Decision Date: Dec 20, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Bre.comp is intended to restore carious lesions or structural defects in teeth.

Device Story

Bre.comp is a light-curing microhybrid dental restorative material; used by dental professionals for anterior and posterior restorations. Input consists of the resin material applied to prepared tooth structures; material is light-cured to harden. Output is a restored tooth surface or structure. Used in dental clinics; provides structural and aesthetic repair of carious lesions or defects. Benefits include restoration of tooth function and anatomy.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing and comparison to predicate device performance characteristics.

Technological Characteristics

Microhybrid composite based on BIS-GMA resins and inorganic fillers (0.05 to 0.09 µm particle size). Total filler content: 81% weight, 63% volume. Complies with DIN EN ISO 4049. Light-curing energy source.

Indications for Use

Indicated for restoration of carious lesions or structural defects in teeth, including cavity classes I to V, inlays, veneers (direct and indirect), crown suprastructures, and post and core buildups.

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

• Vivadent (USA) Inc. (K790439)

Submission Summary (Full Text)

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DEC 2 0 2005

K052779

# >>Summary of Safety & Effectiveness

# 510(k) Summary as required by section 807.92(c)

Date: 01:16/05

Submission Applicant: Bredent - Products for the dental tecnnician laboratory Weissenhornerstr. 2 89250 Senden

Phone: xx49-7309-872-230 Fax: xx49-7309-872-24 E-mail: [e-mail]

Establishment Registration Number: 1000303432

Application corresondent/Contact person: think – healthcare management Schwarzwaldstr. 11 D-78532 Tuttlingen/Germany

Phone: xx49-7462-91300 Fax: xx49-7462-91301 E-mail: [e-mail]

Trade name: Bredent - Bre.comp

Common name: Tooth shade resin material

Classfication name: Tooth shade resin material, Dental (21 CFR 872.3690 - EBF)

Substantial Equivalence Claim: K790439 - Vivadent (USA) Inc.

#### Description of the Device:

Bre.comp dentine/enamel/transparent is a light curing microhybride for anterior and posterior restorations. Bre.comp is based on BIS-GMA resins and inorganic fillers with particle size of 0.05 to 0.09 µm. The total filler content is 81% (weight percent) and 63% (volume percent). The composite material complies with the requirements of DIN EN ISO 4049

Application range:

Universal dental restorative material for the following indications:

- cavity classes I to V

- inlays, veneers (direct and indirect)

- crown suprastructures

- post and core buildups

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#### Indications for Use:

Bre.comp is intended to restore carious lesions or structural defects in teeth

### Comparison with P.D.

The Bredent product is similiar to the P.D. in terms of technical characteristics, design, Indications for Use, Target population, where it is used, performance, biocompatibility characteristics as well as sizes and configurations. Therefore the Bredent product can be deemed substantially equivalent and safe and effective for its indicated use.

#### Summary

The presented data that was conducts shows in its results and in comparison to the predicate devices that the products are absolutely safe and effective for their intended use and do not raise any questions regarding sofety and effectiveness. All models that are covered by this 510(k) premarket natification have been on the market in Europe for many years with no device failures. The used materials are well researched and do not raise any kind of question regarding safety and effectiveness of the finished product.

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Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized image of an eagle.

DEC 2 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Bredent C/O Mr. Markus Denk Think - Healthcare Management Schwarzwaldstr. 11 D-78532 Tuttlingen GERMANY

Re: K052779

Trade/Device Name: Brecomp Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: November 09, 2005 Received: November 16, 2005

Dear Mr. Denk:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your over contribut the device is substantially equivalent (for the indications for referenced above and nero to legally marketed predicate devices marketed in interstate commerce ass stated in the energians) to etment date of the Medical Device Amendments, or to devices that provisions of the First, and cordance with the provisions of the Federal Food, Drug, and Cosmetic nate occirrest 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 therefore, manier are 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 rr your device to such additional controls. Existing major regulations affecting your device can be may be subject to can a lot a many and to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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## Page 2 - Mr. Markus Denk

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that 117A 's issualice of a succession of the requirements of the Act of that FDA has made a determination that your are reveal agencies. You must comply with and regulations and regional starts Bard 807): any Federal statules and regulations administered of battle istration and listing (21 CFR Part 877);
all the Act's requirements, including, but not limited to: registration all the Act s requirements, including, but not manufacturing as set forth in the quality.
Iabeling (21 CFR Part 801); good manufacturing practice requirement as set forther s labeling (21 CFR Part 801), good manageanage provilicable, the electronic product radiation systems (QB) regalaters (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) I his letter will anow you to ocgin maneting your antial equivalence of your device to a legally premarket noutication. The IDA miding of bactuallian of the may of the spermits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your accuse the same and the regulation entitled, contact the Office of Compilance at (210) 27 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small general intolliation on your responsionnies and its toll-free number [phone] or Manufacturers, International and Colisanel Processes of cath/industry/support/index.html.

Sincerely yours,

Sialyte Y. Michie MD.

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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K 052779

# Indications for Use

K052779

510(k) Number (if known):

Device Name: Brecomp

**Indications For Use:**

Indications For Use: Brecomp is intended to restore carious lesions or structural defects in teeth.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sivan Juarez

Image /page/4/Picture/13 description: The image shows a document with some text. The text at the top reads "General Hospital" and "Dental Devices". Below this, there is a handwritten number "K052779". The document appears to be a record or form with some identifying information.

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