# K974487: Seac Advanced Dental System - Model 2001,2010 or Model 2020

- Pathway: 510(k) (Traditional)
- Applicant: Asi Medical, Inc.
- Decided: Feb 18, 1998 after 84 days
- Product code: EIA (Unit, Operative Dental)
- Device class: 1
- Regulation: 21 CFR 872.6640
- Recalls of this device: 1 (0 Class I)
- 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.

## Recalls of this device
- Nov 5, 2013 · Class II · Z-0545-2014: ASI Medical is initiating a field correction for the SEAC Advanced Dental System because the miniature plastic air tank can potentially rupture.

## Indications for use
SEAC System is a self-contained dental delivery system with a built-in air compressor, vacuum systems and water supply. It is designed operate dental handpiece to include a Micadent air abrasion system mounted inside the unit with the handpiece mounted in aholder.dongfidethamm The Micadent is used to perform intra-oral

Source page: https://510kreport.com/device/K974487
Methodology: https://510kreport.com/methodology