(113 days)
Nobel Biocare's Procera® Bridge Laminate is indicated for use as a core structure of an artificial prosthesis to replace a missing tooth between surrounding remaining teeth in the esthetic region. The bridge is bonded onto natural teeth.
Nobel Biocare's Procera® Bridge Laminate serves as a core structure of an artificial prosthesis to replace a missing tooth between surrounding remaining teeth in the esthetic region.
The Procera® Laminate Bridge is two thin lingual laminates and a pontic precision milled from one solid piece of zirconium oxide (Zirconia), which is then veneered with porcelain. After the bridge is veneered by the dental laboratory and sent to the clinician, the completed bridge is cemented or bonded to natural teeth.
This document is a 510(k) summary for a dental device, the Procera® Bridge Laminate. It does not contain information about acceptance criteria or a study proving device performance against such criteria. The document focuses on the device description, indications for use, and a letter from the FDA confirming substantial equivalence to a legally marketed predicate device.
Therefore, I cannot provide the requested information.
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1.4 510(k) Summary of Safety and Effectiveness
| Submitted by: | Phuong Nguyen SonRegulatory Affairs Specialist |
|---|---|
| Address: | Nobel Biocare USA LLC22715 Savi Ranch ParkwayYorba Linda, CA 92887 |
| Telephone: | (714) 282-4800, ext. 7830 |
| Facsimile: | (714) 282-9023 |
| Date of Submission: | October 31, 2005 |
| Classification Name: | Porcelain Tooth (21 CFR 872.3920) |
| Trade or Proprietaryor Model Name: | Procera® Bridge Laminate |
| Legally Marketed Device(s): | Procera® Copings & Pontic (K032562) |
Device Description:
Nobel Biocare's Procera® Bridge Laminate serves as a core structure of an artificial prosthesis to replace a missing tooth between surrounding remaining teeth in the esthetic region.
The Procera® Laminate Bridge is two thin lingual laminates and a pontic precision milled from one solid piece of zirconium oxide (Zirconia), which is then veneered with porcelain. After the bridge is veneered by the dental laboratory and sent to the clinician, the completed bridge is cemented or bonded to natural teeth.
Indications for Use:
Nobel Biocare's Procera® Bridge Laminate is indicated for use as a core structure of an artificial prosthesis to replace a missing tooth between surrounding remaining teeth in the esthetic region. The bridge is bonded onto natural teeth.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 2 2006
Nobel Biocare USA AB C/O Mr. Phuong Nguyen Son Regulatory Affairs Specialist Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887
Re: K053068
Trade/Device Name: Procera Bridge Laminate, Model 40-4002 Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: February 10, 2006 Received: February 13, 2006
Dear Mr. Son:
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, FIDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Son
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 moun that 1 DT may may Federal statutes and regulations administered by other Federal agencies. or not 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 and if the (- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - requirements as betrenir 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) ring letter notification. The FDA finding of substantial equivalence of your device to a premaired tourseand 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), 11 you dontact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the maj South Small Manufacturers, International and Consumer 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.
Sincercly yours,
Chiu Lin, Ph.D.
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
K053068 510(k) Number (if known):
Device Name: Procera Bridge Laminate
Indications For Use:
Nobel Biocare's Procera Bridge Laminate is indicated for use as a core structure of an artificial prosthesis to replace a missing tooth between surrounding remaining teeth in the esthetic region. The bridge is bonded onto natural teeth.
× Prescription Use (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)
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§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)