Cleared Traditional

Straumann TLX Novaloc and Cementable Abutments

K203355 · Institut Straumann AG · Dental

Feb 2021

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K203355 is an FDA 510(k) clearance for the Straumann TLX Novaloc and Cementable Abutments, 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 February 12, 2021, 88 days after receiving the submission on November 16, 2020. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K203355 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 16, 2020
Decision Date	February 12, 2021
Days to Decision	88 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.