FDA · official record K984609Substantially Equivalent

ADEC DENTAL UNIT, MODELS CENTURY PLUS & CASCADE, DCI DENTAL UNIT, MODEL SERIES III

Name: ADEC DENTAL UNIT, MODELS CENTURY PLUS & CASCADE, DCI DENTAL UNIT, MODEL SERIES III — FDA K984609
Creator: Lite Specialty Metal Works, Inc.
Keywords: ADEC DENTAL UNIT, MODELS CENTURY PLUS & CASCADE, DCI DENTAL UNIT, MODEL SERIES III, ADEC DENTAL UNIT, MODELS CENTURY PLUS & CASCADE, DCI DENTAL UNIT, MODEL SERIES III, K984609, EIA, FDA

United StatesEIALite Specialty Metal Works, Inc.

Verified

Official record identity

FDA application number: K984609
Decision date: February 09, 1999
Published decision: Substantially Equivalent

Classification

Product code: EIA

Published parties

Applicant: Lite Specialty Metal Works, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1998-12-28
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.