FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

This document is a 510(k) clearance letter from the FDA for a dental alloy named "Stabilor HN". It does not contain any information about acceptance criteria or a study proving device performance. This letter is simply an approval to market the device based on its substantial equivalence to previously marketed devices.

Therefore, I cannot provide the requested information as it is not present in the provided document.

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K Number

K972910

Device Name

PORS ON LITE

Manufacturer

DEGUSSA CORP.

Date Cleared

1997-10-14

(68 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Alloy: Porcelain Fused To Metal Crowns -Full Metal Crowns - Bridges of any span length

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental alloy, specifically "PORS ON LITE". This document does not contain information about acceptance criteria, device performance studies, or details relevant to artificial intelligence (AI) devices.

Therefore, I cannot fulfill your request to describe acceptance criteria and associated study details based on this input text. The information you are looking for (like sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not present in this regulatory clearance document.

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K Number

K960256

Device Name

DEGUDENT LS

Manufacturer

DEGUSSA CORP.

Date Cleared

1996-02-21

(34 days)

Product Code