Cleared Traditional

Straumann Variobase C

K192742 · Institut Straumann AG · Dental

Feb 2021

Decision

501d

Days

Class 2

Risk

About This 510(k) Submission

K192742 is an FDA 510(k) clearance for the Straumann Variobase C, a Abutment, Implant, Dental, Endosseous (Class II — Special Controls, product code NHA), submitted by Institut Straumann AG (Grafelfing, DE). The FDA issued a Cleared decision on February 12, 2021, 501 days after receiving the submission on September 30, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K192742 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 30, 2019
Decision Date	February 12, 2021
Days to Decision	501 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.