# K983661: Belmont Unit, Model 6000 Series and 7500 Series

- Pathway: 510(k) (Traditional)
- Applicant: Belmont Equipment Corp.
- Decided: Jan 12, 1999 after 85 days
- Product code: EIA (Unit, Operative Dental)
- Device class: 1
- Regulation: 21 CFR 872.6640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
DENTAL UNIT AND ACCESSORIES ARE INTENDED FOR THE DENTISTS, HYGENISTS, AND DENTAL ASSISTANTS FOR TRADITIONAL AND NORMAL PATIENT TREATMENT 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.

Source page: https://510kreport.com/device/K983661
Methodology: https://510kreport.com/methodology