(103 days)
The NobelProcera Implant Bridge Zirconia is indicated for use as a bridge framework in the treatment of partially or totally edentulous jaws for the purpose of restoring function.
Nobel Biocare's NobelProcera Implant Bridge Zirconia is a bridge framework that attaches to implants or abutments. The NobelProcera Implant Bridge Zirconia is intended to be finished into a dental prosthesis using standard laboratory dental materials such as resin composite or porcelain veneer.
The NobelProcera Implant Bridge Zirconia is made individually following instructions and models specific to each patient. The NobelProcera Implant Bridge Zirconia is made entirely of zirconia.
The provided document does not contain any information regarding clinical studies, acceptance criteria, or performance data for the NobelProcera Implant Bridge Zirconia device.
The document is a 510(k) summary and FDA decision letter for a dental device. It focuses on:
- Device Description: What the device is (a bridge framework made of zirconia).
- Indications for Use: How the device is intended to be used (for restoring chewing function in partially or totally edentulous jaws).
- Substantial Equivalence: The FDA's determination that the device is substantially equivalent to legally marketed predicate devices, meaning it doesn't require a Pre-Market Approval (PMA) application.
- Regulatory Information: Classification, product code, and general regulatory requirements.
Therefore, it is impossible to answer any of the questions below based on the provided text, as it does not include details about device performance, studies, ground truth, or expert involvement.
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510(k) Summary of Safety and Effectiveness 1.4
OCT - 6 2009
| Submitted by: | Herbert Crane, Director Global Regulatory Affairs |
|---|---|
| Address: | Nobel Biocare USA LLC22715 Savi Ranch ParkwayYorba Linda, CA 92887 |
| Telephone: | (714) 282-4800, ext. 5074 |
| Facsimile: | (714) 998-9348 |
| Date of Submission: | June 24, 2009 |
| Classification Name: | Endosseous Dental Implant Abutment (21 CFR 872.3630) |
| Trade or Proprietaryor Model Name: | NobelProcera Implant Bridge Zirconia |
| Legally Marketed Devices: | Nobel Biocare - Procera Implant Bridge Overdenture (K090069)Nobel Biocare - Procera Implant Bridge Zirconia (K053091) |
Device Description:
Nobel Biocare's NobelProcera Implant Bridge Zirconia is a bridge framework that attaches to implants or abutments. The NobelProcera Implant Bridge Zirconia is intended to be finished into a dental prosthesis using standard laboratory dental materials such as resin composite or porcelain veneer.
The NobelProcera Implant Bridge Zirconia is made individually following instructions and models specific to each patient. The NobelProcera Implant Bridge Zirconia is made entirely of zirconia.
Indications for Use:
The NobelProcera Implant Bridge Zirconia is indicated for use as a bridge framework in the treatment of partially or totally edentulous jaws for the purpose of restoring function.
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Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains an emblem of an eagle with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are written around the top half of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002
Nobel Biocare AB C/O Mr. Herbert Crane Director, Global Regulatory Affairs Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887
OCT - 6 2009
Re: K091907
Trade/Device Name: NobelProcera Implant Bridge Zirconia Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: September 22, 2009 Received: September 22, 2009
Dear Mr. Crane:
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 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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Image /page/2/Picture/2 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Page 2- Mr. Crane
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring. MD 20993-0002
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/SafetyReporta Problem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
for
Susan Runner, D.D.S., M.A. Acting 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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510(k) Number (if known):
Device Name: NobelProcera Implant Bridge Zirconia
Indications For Use:
The NobelProcera Implant Bridge Zirconia is indicated for use as a bridge framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.
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)
Kesia Mulry for MSN
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of 1
510(k) Number: K091907
§ 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.)