FDA · official record K943486Substantially Equivalent

ORAFIX SPECIAL DENTURE ADHESIVE

Name: ORAFIX SPECIAL DENTURE ADHESIVE — FDA K943486
Creator: Smithkline Beecham Corp.
Keywords: ORAFIX SPECIAL DENTURE ADHESIVE, ORAFIX SPECIAL DENTURE ADHESIVE, K943486, KOO, FDA

United StatesKOOSmithkline Beecham Corp.

Verified

Official record identity

FDA application number: K943486
Decision date: November 03, 1994
Published decision: Substantially Equivalent

Classification

Product code: KOO

Published parties

Applicant: Smithkline Beecham Corp.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1994-07-19
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.3490

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.