FDA · official record K111178Substantially Equivalent

JUELL SOFT CURE

Name: JUELL SOFT CURE — FDA K111178
Creator: Juell Dental
Keywords: JUELL SOFT CURE, JUELL SOFT CURE, K111178, EBI, FDA

United StatesEBIJuell Dental

Verified

Official record identity

FDA application number: K111178
Decision date: September 12, 2011
Published decision: Substantially Equivalent

Classification

Product code: EBI

Published parties

Applicant: Juell Dental

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2011-04-27
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3760

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.