FDA · official record K992629Substantially Equivalent

D/SENSE II (GREEN-OR) DENTIN DESENSITIZER

Name: D/SENSE II (GREEN-OR) DENTIN DESENSITIZER — FDA K992629
Creator: Centrix, Inc.
Keywords: D/SENSE II (GREEN-OR) DENTIN DESENSITIZER, D/SENSE II (GREEN-OR) DENTIN DESENSITIZER, K992629, LBH, FDA

United StatesLBHCentrix, Inc.

Verified

Official record identity

FDA application number: K992629
Decision date: October 22, 1999
Published decision: Substantially Equivalent

Classification

Product code: LBH

Published parties

Applicant: Centrix, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1999-07-28
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.