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K Number
K983161
Device Name
KURER CROWN SAVER K4 ANCHOR SYSTEM-THE UNIVERSAL KIT, KURER STANDARD K4 ANCHOR SYSTEM- THE READY CORE KIT, KURER FIN-LOC
Manufacturer
SABRE-K LTD.
Date Cleared
1998-09-30

(21 days)

Product Code
ELR
Regulation Number
872.3810
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The K4 products fall into the general category of prefabricated (preformed) posts which comprises threaded and non-threaded versions. The K4 system is designed is designed so that the posts are cemented into canals tapped previously with a thread. This means that the K4 system is pre-threaded and therefore placement is passive (not active) as the posts themselves are not cutting into the dentine at the cementation stage. If placed in accordance with the instructions the process will largely eliminate fitting stress.

Posts are placed to support a core so that a crown can complete a tooth restoration, or to stop the coronal tooth substance from shearing off.

The introduction of titanium versions of certain of the K4 products does not change the method or the purpose of the placement. The dentist is simply to be offered a choice of post material. We will not seek to influence the dentist's decision.

Device Description

Not Found

AI/ML Overview

I am sorry, but I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text.

Here's why:

  • The document is a 510(k) clearance letter. This type of document from the FDA states that a device is "substantially equivalent" to a legally marketed predicate device. It is not a clinical study report or a document detailing performance specifications and test results.
  • Lack of acceptance criteria and study details. The letter explicitly states that the FDA has reviewed the 510(k) notification and determined substantial equivalence. It does not contain sections outlining specific performance acceptance criteria, study methodologies, sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness study results. These details would typically be found in the 510(k) submission itself, which is not provided here.
  • Focus on regulatory classification. The document's primary purpose is to inform the applicant that their device (Kurer Crown Saver K4 Anchor System) can be legally marketed, subject to general controls, because it's substantially equivalent to existing devices.

Therefore, the information you requested regarding acceptance criteria, study details, and performance metrics is simply not present in the provided text.

§ 872.3810 Root canal post.

(a)
Identification. A root canal post is a device made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended to be cemented into the root canal of a tooth to stabilize and support a restoration.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.