# K052574: Compact Plus - Extreme - Perfect Plus

- Pathway: 510(k) (Traditional)
- Applicant: J.O. Suarez & Cia, Ltda
- Decided: Jul 17, 2006 after 301 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
THESE DENTAL CHAIRS ARE AC-POWERED AND INTENDED TO PROPERLY POSITION A PATIENT TO PERFORM ROUTINE DENTAL PROCEDURES. ITS ATTACHEL OPERATIVE DENTAL UNIT IS INTENDED TO SERVE AS A BASE FOR OTHER DENTAl DEVICES, SUCH AS DENTAL HAND PIECES, AIR OR WATER SYRINGE UNIT ANE OTHER DENTAL DEVICES AND ACCESSORIES. THESE DENTAL UNITS DO NOT HAVE ANY INSTRUMENTORDEVICETHATMAYBE USED ONTHE PATIENT.

Source page: https://510kreport.com/device/K052574
Methodology: https://510kreport.com/methodology