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

DENTAL UNIT AND ACCESSORIES ARE INTENDED FOR THE DENTISTS, AND DENTAL ASSISTANTS FOR TRADITIONAL AND NORMAL PATIENT PROCEDURES IN THE DENTAL OPERATORY. THE DESIGN FUNCTION, AND POSITIONING OF THE UNIT AND ACCESSORIES ARE SIMILAR TO MOST ALL OTHER DENTAL UNITS MANUFACTURED FOR THIS SPECIFIC PURPOSE OVER THE PAST TWENTY YEARS.

Device Description

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AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, study details, sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The provided document is a 510(k) clearance letter from the FDA for a dental unit and accessories, stating that the device is substantially equivalent to legally marketed predicate devices. It covers regulatory aspects, product codes, and general information about marketing the device, but it does not delve into the specific details of performance studies or acceptance criteria.

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K Number

K963699

Device Name

BELRAY/MODEL 096, DENTAL INTRAORAL X-RAY

Manufacturer

BELMONT EQUIPMENT CORP.

Date Cleared

1996-12-23

(98 days)

Product Code