FDA · official record K191919Substantially Equivalent

Elos Accurate Hybrid Base

Name: Elos Accurate Hybrid Base — FDA K191919
Creator: Elos Medtech Pinol A/S
Keywords: Elos Accurate Hybrid Base, Elos Accurate Hybrid Base, K191919, NHA, FDA

United StatesNHAElos Medtech Pinol A/S

Verified

Official record identity

FDA application number: K191919
Decision date: February 10, 2020
Published decision: Substantially Equivalent

Classification

Product code: NHA

Published parties

Applicant: Elos Medtech Pinol A/S

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2019-07-18
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3630

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.