FDA · official record K974487Substantially Equivalent

SEAC ADVANCED DENTAL SYSTEM - MODEL 2001,2010 OR MODEL 2020

Name: SEAC ADVANCED DENTAL SYSTEM - MODEL 2001,2010 OR MODEL 2020 — FDA K974487
Creator: Asi Medical, Inc.
Keywords: SEAC ADVANCED DENTAL SYSTEM - MODEL 2001,2010 OR MODEL 2020, SEAC ADVANCED DENTAL SYSTEM - MODEL 2001,2010 OR MODEL 2020, K974487, EIA, FDA

United StatesEIAAsi Medical, Inc.

Verified

Official record identity

FDA application number: K974487
Decision date: February 18, 1998
Published decision: Substantially Equivalent

Classification

Product code: EIA

Published parties

Applicant: Asi Medical, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1997-11-26
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.6640

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.