Cleared Traditional

Lumina-PTFE Titanium

K221851 · Criteria Industria E Comercio DE Produtos Medicinais · Dental

Dec 2023

Decision

529d

Days

Class 2

Risk

About This 510(k) Submission

K221851 is an FDA 510(k) clearance for the Lumina-PTFE Titanium, a Barrier, Synthetic, Intraoral (Class II — Special Controls, product code NPK), submitted by Criteria Industria E Comercio DE Produtos Medicinais (Sao Carlos, BR). The FDA issued a Cleared decision on December 8, 2023, 529 days after receiving the submission on June 27, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number	K221851 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 27, 2022
Decision Date	December 08, 2023
Days to Decision	529 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF

Device Classification

Product Code	NPK — Barrier, Synthetic, Intraoral
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 872.3930
Definition	A Synthetic Dental Barrier Is A Synthetic Material Device, Such As Ptfe, Intended To Aid In Guided Tissue And/or Bone Regeneration Procedures And To Act As A Stable Barrier For The Containment Of Bone Graft Materials.