# K050571: Absolute America

- Pathway: 510(k) (Abbreviated)
- Applicant: Eurodent S.P.A.
- Decided: Nov 2, 2005 after 243 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. The FDA summary names its predicate without a number.
- (no number) Castellini S.p.A. dental operative unit model "Logos Junior": named in the summary without a submission number
- (no number) American Dental Technologies dental operative unit model "Gulliver": named in the summary without a submission number
- (no number) American Dental Technologies dental operative unit model "Classe A Dental Operative Unit": named in the summary without a submission number

## Indications for use
Absolute America is a dental operative unit intended as an operative tool for therapeutic use on people by personnel highly skilled in dental practices, such as dentists, dental assistants and dental hygienists.

Source page: https://510kreport.com/device/K050571
Methodology: https://510kreport.com/methodology