(67 days)
Bredent Breformance is intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.
breformance ColdCuringPolymer is a C+B material for temporary restorations
This document is a 510(k) summary for the Bredent Breformance temporary crown and bridge resin. It does not contain any information regarding acceptance criteria, device performance tables, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance studies.
The document states that:
- The Bredent product is similar to a predicate device (K013869 - Ivoclar Vivadent, Inc.) in terms of technical characteristics, design, indications for use, target population, where it is used, performance, biocompatibility, and sizes/configurations.
- The presented data (which is not included in the provided text) shows that the products are "absolutely safe and effective for their intended use."
- All models have been on the market in Europe for many years "with no device failures."
- The materials used are "well researched and do not raise any kind of question regarding safety and effectiveness of the finished product."
Therefore, based solely on the provided text, I cannot describe the acceptance criteria or the study that proves the device meets them because that information is not present. The submission relies on substantial equivalence to a predicate device and anecdotal evidence of market history in Europe.
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»Summary of Safety & Effectiveness
510(k) Summary as required by section 807.92(c)
Date: 03/16/05
Submission Applicant: Bredent - Products for the dental technician aboratory Weissenhornerstr. 2 89250 Seriden
Phone: xx49-7309-872-230 Fax: xx49-7309-872-24 E-mail: info@bredent.com
Estabiishment Registration Number: 1000303432
Application corresondent/Contact person: think - healthcare management Schwarzwaldstr. ↑ 1 D-78532 Tuttlingen Germany
Phone: xx49.7462-91300 Fcx: xx49-7462-9 1301 E-mail: denk@denkgruppelde
Trade name: Bredent - Breformance
Common name: Temporary crown and bridge resin
Classfication name:
Temporary crown and bridge resin, Dentol (21 CFR 872.3770 - EBG)
Substantial Equivalence Claim: K013869 - Ivoclar Vivadent, Inc.
Description of the Device:
breformance ColdCuringPolymer is a C+B material for temporary restorations
Application range:
Temporary crowns and bridges, long-term temporary restorations, extraoral repars, covering attachments in combined dentures, fixation of milled acrylic teeth on CoCr dentures
Indications for Use:
Bredent Breformance is intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.
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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, biocomatibility characteristics as well as sizes and configurations. Therefore the Bredent product can be deemed substantially equivalent and sofe and effective for its indicated use.
Summary
The presented data that was conducted on the Bredent products shows 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 safety and effectiveness. All models that are covered by this 510(k) premarket notification have been on the market in Europe for mony 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/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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 9 2005
Bredent C/O Mr. Markus Denk Think - Healthcare Management Schwarzwaldstr. 11 D-78532 Tuttlingen GERMANY
Re: K052781
Trade/Device Name: Breformance Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown & Bridge Resin Regulatory Class: II Product Code: EBG 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 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 - Mr. Markus Denk
Please be advised that FDA's issuance of a substantial equivalence determination does not mean 1 Nase be advised this I Dr. F b issualled to but 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); an the Act 3 requirements) i seod manufacturing practice requirements as set forth in the quality iablems (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) I ms letter will and in yourse FDA finding of substantial equivalence of your device to a legally premaired notification. " the sification 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 If you don't office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other I Nisolanding of responsibilities under the Act from the Division of Small general invinution on your assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Shutte 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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Indications for Use
510(k) Number (if known): K052781
Device Name: Bredent Breformance
Indications For Use: Bredent Breformance is intended to make temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.
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)
Susa Ruaser
14
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§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.