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K Number
K050515
Device Name
BONE BLOCK FIXATION SET
Manufacturer
STRAUMANN USA, INC.
Date Cleared
2005-04-05

(35 days)

Product Code
DZL
Regulation Number
872.4880
Type
Special
Panel
DE
Reference & Predicate Devices
K011698
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Straumann Bone Block Fixation is used to stabilize and fixate bone grafts and bone filling materials for the regeneration of bone in the oral cavity. The bone grafting fixation technique can make it possible for the placement of dental implants in previously unsuitable sites.

Device Description

Straumann Bone Block Fixation includes a cassette, instruments, and screws that are slight modifications of ones previously cleared by FDA under K011698. Modification to the instruments and screws are in dimensions only.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Straumann Bone Block Fixation Set." This submission seeks to establish substantial equivalence to a legally marketed predicate device, the "Guided Bone Regeneration System (K011698)."

However, the provided document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory submission focused on demonstrating substantial equivalence based on

  • Intended Use: The same as the predicate device (stabilizing and fixating bone grafts and bone filling materials for bone regeneration in the oral cavity).
  • Device Characteristics: The screws and instruments are similar, and in some cases identical, to the predicate device, with modifications only in dimensions. The material (CP Grade 4 titanium) is also identical.

Therefore, I cannot provide the requested information as it is not present in the given text. The document is a 510(k) summary and the FDA's response letter, which asserts substantial equivalence, not a detailed technical report discussing performance studies against specific acceptance criteria.

To answer your request, a different type of document, such as a validation report, performance study, or clinical trial summary, would be required.

§ 872.4880 Intraosseous fixation screw or wire.

(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.