FDA · official record K181888Substantially Equivalent

Osstell Beacon

Name: Osstell Beacon — FDA K181888
Creator: Osstell AB
Keywords: Osstell Beacon, Osstell Beacon, K181888, EKX, FDA

United StatesEKXOsstell AB

Verified

Official record identity

FDA application number: K181888
Decision date: August 22, 2019
Published decision: Substantially Equivalent

Classification

Product code: EKX

Published parties

Applicant: Osstell AB

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2018-07-13
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.4200

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.