FDA · official record K862590Substantially Equivalent

3M ESTHETIC DESIGN SYSTEM (TINTS & MASKING AGENTS)

Name: 3M ESTHETIC DESIGN SYSTEM (TINTS & MASKING AGENTS) — FDA K862590
Creator: 3M Company
Keywords: 3M ESTHETIC DESIGN SYSTEM (TINTS & MASKING AGENTS), 3M ESTHETIC DESIGN SYSTEM (TINTS & MASKING AGENTS), K862590, EBD, FDA

United StatesEBD3M Company

Verified

Official record identity

FDA application number: K862590
Decision date: July 22, 1986
Published decision: Substantially Equivalent

Classification

Product code: EBD

Published parties

Applicant: 3M Company

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1986-07-07
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3310

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.