FDA · official record K891338Substantially Equivalent

SMYLON (DENTAL STAIN ERASER)

Name: SMYLON (DENTAL STAIN ERASER) — FDA K891338
Creator: The Smylon Co.
Keywords: SMYLON (DENTAL STAIN ERASER), SMYLON (DENTAL STAIN ERASER), K891338, MAU, FDA

United StatesMAUThe Smylon Co.

Verified

Official record identity

FDA application number: K891338
Decision date: November 14, 1989
Published decision: Substantially Equivalent

Classification

Product code: MAU

Published parties

Applicant: The Smylon Co.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1989-03-13
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.6855

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.