(85 days)
The Procera 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.
In addition to Nobel Biocare implant systems, the Procera Implant Bridge Zirconia can be used on the following implant systems:
- Straumann Dental Implant System Regular Neck 4.8
- Straumann Dental Implant System Wide Neck 6.5
- 31 3.75
- Lifecore Biomedical Restore 3.75
- Zimmer Dental Taper-Lock 4.0
- Sterngold Implamed 3.75
Procera® Implant Bridge Zirconia is a dental prosthetic framework milled from one solid piece of Zirconia (zirconium oxide). The many endosseous implant interfaces that can be used in the Procers" implant Bridge Zirconia are precision milled and are an integral part of the framework.
The Procera® Implant Bridge Zirconia can be precision milled for two (2) to eight (8) units. The bridge is to function as a load-bearing device for implant-anchored prosthetics.
The Procera® Implant Bridge Zirconia is a packaged as a semi-finished, non-sterile, device and delivered to the dental laboratory for veneering and completion. The final, veneered, Procera® Implomation and colle Zirconia is delivered from the dental laboratory to the clinician.
This request cannot be fulfilled due to the nature of the provided document. The document is an FDA 510(k) summary for a dental prosthetic framework (Procera® Implant Bridge Zirconia). It describes the device, its indications for use, and confirms its substantial equivalence to predicate devices.
However, the 510(k) summary does not contain any information about clinical studies, acceptance criteria, or performance data that would be required to answer the specific questions posed, such as:
- Acceptance criteria and reported device performance: This document doesn't present a table of such.
- Sample size and data provenance for a test set: No test set is mentioned.
- Number of experts and their qualifications for ground truth: No expert review for ground truth is mentioned.
- Adjudication method: Not applicable as no ground truth establishment is described.
- MRMC comparative effectiveness study: No such study is mentioned.
- Standalone algorithm performance: This is a physical dental device, not an algorithm.
- Type of ground truth used: Not applicable for a device of this nature in this document.
- Sample size for training set/How ground truth for training set was established: Not applicable for a physical device.
The 510(k) process for devices like this primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, often through engineering analysis, material testing, and similarity in design and intended use, rather than clinical efficacy studies with specific performance metrics and ground truth as would be seen for, for example, diagnostic AI devices.
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510(k) Summary of Safety and Effectiveness 1.4
| 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: | November 2, 2005 |
| Classification Name: | Endosseous Implant (21 CFR 872.3640) |
| Trade or Proprietaryor Model Name: | Procera® Implant Bridge Zirconia |
| Legally Marketed Device(s): | Procera® Implant Bridge (K043042)Procera® Implant Bridge (K041236) |
Device Description:
Procera® Implant Bridge Zirconia is a dental prosthetic framework milled from one solid piece of Zirconia (zirconium oxide). The many endosseous implant interfaces that can be used in the Procers" implant Bridge Zirconia are precision milled and are an integral part of the framework.
The Procera® Implant Bridge Zirconia can be precision milled for two (2) to eight (8) units. The bridge is to function as a load-bearing device for implant-anchored prosthetics.
The Procera® Implant Bridge Zirconia is a packaged as a semi-finished, non-sterile, device and delivered to the dental laboratory for veneering and completion. The final, veneered, Procera® Implomation and colle Zirconia is delivered from the dental laboratory to the clinician.
Indications for Use:
The Procera® 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.
In addition to Nobel Biocare implant systems, the Procera® Implant Bridge Zirconia can be used on the following implant systems:
- Straumann Dental Implant System Regular Neck 4.8 י
- Straumann Dental Implant System Wide Neck 6.5 "
- -31 3.75
- -Lifecore Biomedical Restore 3.75
- Zimmer Dental Taper-Lock 4.0 -
- -Sterngold Implamed 3.75
Nobel Biocare USA Traditional 510(k) Notification Procera® Implant Bridge Zirconia November 2005
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Image /page/1/Picture/2 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 representing its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.
JAN 2 7 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nobel Biocare AB C/O Mr. Phuong Nguyen Son Regulatory Affairs Specialist Nobel Biocare USA, LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887
Re: K053091
Trade/Device Name: Procera Implant Bridge Zirconia Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: November 22, 2005 Received: November 23, 2005
Dear Mr. Nguyen 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 8010 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Nguyen 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 agencines. 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 : regative 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, parmits 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Spatz y Michael Diaz.
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
KOS3091 510(k) Number (if known):
Device Name: Procera Implant Bridge Zirconia
Indications For Use:
The Procera 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.
In addition to Nobel Biocare implant systems, the Procera Implant Bridge Zirconia can be used on the following implant systems:
- Straumann Dental Implant System Regular Neck 4.8
- Straumann Dental Implant System Wide Neck 6.5
- 31 3.75
- Lifecore Biomedical Restore 3.75
- Zimmer Dental Taper-Lock 4.0
- Sterngold Implamed 3.75
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)
Susan Rumer
Page 1 of 1
1.3
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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.)