FDA · official record K221851Substantially Equivalent

Lumina-PTFE Titanium

Name: Lumina-PTFE Titanium — FDA K221851
Creator: Criteria Industria E Comercio DE Produtos Medicinais
Keywords: Lumina-PTFE Titanium, Lumina-PTFE Titanium, K221851, NPK, FDA

United StatesNPKCriteria Industria E Comercio DE Produtos Medicinais

Verified

Official record identity

FDA application number: K221851
Decision date: December 08, 2023
Published decision: Substantially Equivalent

Classification

Product code: NPK

Published parties

Applicant: Criteria Industria E Comercio DE Produtos Medicinais

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2022-06-27
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3930

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.