FDA · official record K933656Substantially Equivalent

JEDENTAL PSROFILL SELF-CURE COMPOSITE

Name: JEDENTAL PSROFILL SELF-CURE COMPOSITE — FDA K933656
Creator: Jedental Co., Inc.
Keywords: JEDENTAL PSROFILL SELF-CURE COMPOSITE, JEDENTAL PSROFILL SELF-CURE COMPOSITE, K933656, EBF, FDA

United StatesEBFJedental Co., Inc.

Verified

Official record identity

FDA application number: K933656
Decision date: November 17, 1993
Published decision: Substantially Equivalent

Classification

Product code: EBF

Published parties

Applicant: Jedental Co., Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1993-07-27
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3690

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.