FDA · official record K994190Substantially Equivalent

IMPREGUM GARANT L DUOSOFT

Name: IMPREGUM GARANT L DUOSOFT — FDA K994190
Creator: Espe Dental AG
Keywords: IMPREGUM GARANT L DUOSOFT, IMPREGUM GARANT L DUOSOFT, K994190, ELW, FDA

United StatesELWEspe Dental AG

Verified

Official record identity

FDA application number: K994190
Decision date: January 27, 2000
Published decision: Substantially Equivalent

Classification

Product code: ELW

Published parties

Applicant: Espe Dental AG

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1999-12-13
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3660

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.