FDA · official record K040858Substantially Equivalent

ORALIEF THERAPY FOR SENSITIVE TEETH

Name: ORALIEF THERAPY FOR SENSITIVE TEETH — FDA K040858
Creator: Novamin Technology, Inc.
Keywords: ORALIEF THERAPY FOR SENSITIVE TEETH, ORALIEF THERAPY FOR SENSITIVE TEETH, K040858, LBH, FDA

United StatesLBHNovamin Technology, Inc.

Verified

Official record identity

FDA application number: K040858
Decision date: September 02, 2004
Published decision: Substantially Equivalent

Classification

Product code: LBH

Published parties

Applicant: Novamin Technology, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2004-04-02
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3260

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.