Lumina-PTFE Titanium— 510(k) K221851

Name: FDA 510(k) clearance K221851
Creator: U.S. Food and Drug Administration
Published: 2023-12-08

Substantially Equivalent

Criteria Industria E Comercio DE Produtos Medicinais

FDA 510(k) clearance K221851 for Lumina-PTFE Titanium, Substantially Equivalent on 2023-12-08. Applicant: Criteria Industria E Comercio DE Produtos Medicinais. Device class: 2.

Clearance details

Applicant: Criteria Industria E Comercio DE Produtos Medicinais
Product code: Code NPK
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2022-06-27
Decision date: 2023-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sao Carlos, BR

Download summary PDF View on FDA.gov ↗

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K201187 — Cytoplast Titanium-Reinforced PTFE Membranes2021-01-23
K171774 — RPM Reinforced PTFE Mesh2017-10-19

Data sourced from openFDA. This site is unofficial and independent of the FDA.