FDA · official record K030859Substantially Equivalent

NOVA CERAMIC SPRAY GLAZE AND TRU-PAQUE, OPAQUE PORCELAIN

Name: NOVA CERAMIC SPRAY GLAZE AND TRU-PAQUE, OPAQUE PORCELAIN — FDA K030859
Creator: Enamelite, LLC
Keywords: NOVA CERAMIC SPRAY GLAZE AND TRU-PAQUE, OPAQUE PORCELAIN, NOVA CERAMIC SPRAY GLAZE AND TRU-PAQUE, OPAQUE PORCELAIN, K030859, EIH, FDA

United StatesEIHEnamelite, LLC

Verified

Official record identity

FDA application number: K030859
Decision date: March 27, 2003
Published decision: Substantially Equivalent

Classification

Product code: EIH

Published parties

Applicant: Enamelite, LLC

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Special
Received date: 2003-03-18
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.6660

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.