FDA · official record K850776Substantially Equivalent

PREFORMED DENTAL IMPRESSION TRAYS

Name: PREFORMED DENTAL IMPRESSION TRAYS — FDA K850776
Creator: L.A.K. Ent., Inc.
Keywords: PREFORMED DENTAL IMPRESSION TRAYS, PREFORMED DENTAL IMPRESSION TRAYS, K850776, EHY, FDA

United StatesEHYL.A.K. Ent., Inc.

Verified

Official record identity

FDA application number: K850776
Decision date: March 18, 1985
Published decision: Substantially Equivalent

Classification

Product code: EHY

Published parties

Applicant: L.A.K. Ent., Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1985-02-26
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.6880

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.