FDA · official record K905324Substantially Equivalent

WILL-CERAM W-1

Name: WILL-CERAM W-1 — FDA K905324
Creator: Ivoclar North America, Inc.
Keywords: WILL-CERAM W-1, WILL-CERAM W-1, K905324, EJT, FDA

United StatesEJTIvoclar North America, Inc.

Verified

Official record identity

FDA application number: K905324
Decision date: December 24, 1990
Published decision: Substantially Equivalent

Classification

Product code: EJT

Published parties

Applicant: Ivoclar North America, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1990-11-28
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3060

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.