FDA · official record K001463Substantially Equivalent

SCHOTTLANDER ENIGMA COLOUR TONE, MODEL 0156

Name: SCHOTTLANDER ENIGMA COLOUR TONE, MODEL 0156 — FDA K001463
Creator: Davis Schottlander & Davis, Ltd.
Keywords: SCHOTTLANDER ENIGMA COLOUR TONE, MODEL 0156, SCHOTTLANDER ENIGMA COLOUR TONE, MODEL 0156, K001463, EBI, FDA

United StatesEBIDavis Schottlander & Davis, Ltd.

Verified

Official record identity

FDA application number: K001463
Decision date: June 16, 2000
Published decision: Substantially Equivalent

Classification

Product code: EBI

Published parties

Applicant: Davis Schottlander & Davis, Ltd.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2000-05-10
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.