FDA · official record K946032Substantially Equivalent

FLUOR PROTECTOR

Name: FLUOR PROTECTOR — FDA K946032
Creator: Ivoclar North America, Inc.
Keywords: FLUOR PROTECTOR, FLUOR PROTECTOR, K946032, LBH, FDA

United StatesLBHIvoclar North America, Inc.

Verified

Official record identity

FDA application number: K946032
Decision date: March 07, 1995
Published decision: Substantially Equivalent

Classification

Product code: LBH

Published parties

Applicant: Ivoclar North America, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1994-12-09
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.