(72 days)
Nobel Biocare's Procera Bridge Zirconia is indicated for use as the core structure of an artificial prosthesis for partially edentulous patients in the need of prosthetic oral reconstruction in order to restore chewing function. The Procera Bridge Zirconia may be cemented or bonded to either natural or artificial tooth abutments.
Nobel Biocare's Procera Bridge Zirconia is a prefabricated device intended for use as the core structure of an artificial prosthesis for placement in the oral cavity in order to restore chewing function. The Procera Bridge Zirconia is precision milled from one solid piece of densely sintered Zirconia, and can be cemented or bonded to either natural or artificial tooth abutments.
The provided text is a 510(k) summary for the Nobel Biocare Procera Bridge Zirconia device. It primarily focuses on the device description, indications for use, and regulatory classification, stating its substantial equivalence to a predicate device.
Crucially, this document does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical validation reports or performance studies. The 510(k) process for this type of device (a Class II Porcelain Tooth) largely relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than on generating new clinical performance data with specific acceptance criteria.
Therefore, for your request, I must report that the requested information is not available within the provided text. The document is a regulatory submission for premarket notification, not a performance study report.
{0}------------------------------------------------
1.4 510(k) Summary of Safety and Effectiveness
| Submitted by: | Ms. 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: | April 26, 2007 |
| Classification Name: | Porcelain Tooth (21 CFR 872.3920) |
| Trade or Proprietaryor Model Name: | Procera Bridge Zirconia |
| Legally Marketed Device(s): | Procera Bridge Zirconia (K053125) |
Device Description:
Nobel Biocare's Procera Bridge Zirconia is a prefabricated device intended for use as the core structure of an artificial prosthesis for placement in the oral cavity in order to restore chewing function. The Procera Bridge Zirconia is precision milled from one solid piece of densely sintered Zirconia, and can be cemented or bonded to either natural or artificial tooth abutments.
Indications for Use:
Nobel Biocare's Procera Bridge Zirconia is indicated for use as the core structure of an artificial prosthesis for partially edentulous patients in the need of prosthetic oral reconstruction in order to restore chewing function. The Procera Bridge Zirconia may be cemented or bonded to either natural or artificial tooth abutments.
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle is black, and the text is in a simple, sans-serif font.
Public Health Service
JUL 1 1 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nobel Biocare AB C/O Phuong Nguyen Son Regulatory Affairs Specialist Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887
Re: K071182
Trade/Device Name: Procera Bridge Zirconia Regulation Number: 21 CFR 872.3920 Regulation Name: Porcelain Tooth Regulatory Class: II Product Code: ELL Dated: April 26, 2007 Received: April 30, 2007
Dear Ms. 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, FDA may publish further announcements concerning your device in the Federal Register.
{2}------------------------------------------------
Page 2 - Ms. 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 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 (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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Clubs
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
{3}------------------------------------------------
Indications for Use
510(k) Number (if known):
Device Name: Procera Bridge Zirconia
Indications For Use:
Nobel Biocare's Procera Bridge Zirconia is indicated for use as the core structure of an artificial prosthesis for partially edentulous patients in the need of prosthetic oral reconstruction in order to restore chewing function. The Procera Bridge Zirconia may cemented or bonded to either natural or artificial tooth abutments.
X 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) |
|---|
| Kein Muly for MSR |
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: Page 1 of 1 ___ KOTI
1.3
§ 872.3920 Porcelain tooth.
(a)
Identification. A porcelain tooth is a prefabricated device made of porcelain powder for clinical use (§ 872.6660) intended for use in construction of fixed or removable prostheses, such as crowns and partial dentures.(b)
Classification. Class II.