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K Number
K091907
Device Name
NOBELPROCERA IMPLANT BRIDGE ZIRCONIA
Manufacturer
NOBEL BIOCARE AB
Date Cleared
2009-10-06

(103 days)

Product Code
NHA
Regulation Number
872.3630
Type
Traditional
Panel
DE
Reference & Predicate Devices
K090069,K053091
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended 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.

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.

AI/ML Overview

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.

§ 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.)