Cleared Traditional

Straumann TLX Variobase C

K220878 · Institut Straumann AG · Dental

Jun 2022

Decision

83d

Days

Class 2

Risk

About This 510(k) Submission

K220878 is an FDA 510(k) clearance for the Straumann TLX Variobase C, a Abutment, Implant, Dental, Endosseous (Class II — Special Controls, product code NHA), submitted by Institut Straumann AG (Basel, CH). The FDA issued a Cleared decision on June 16, 2022, 83 days after receiving the submission on March 25, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K220878 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 25, 2022
Decision Date	June 16, 2022
Days to Decision	83 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF

Device Classification

Product Code	NHA — Abutment, Implant, Dental, Endosseous
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 872.3630
Definition	To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation.