Cleared Traditional

TLX SRAs and TLX Gold Abutments

K213063 · Institut Straumann AG · Dental

Apr 2022

Decision

197d

Days

Class 2

Risk

About This 510(k) Submission

K213063 is an FDA 510(k) clearance for the TLX SRAs and TLX Gold 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 April 8, 2022, 197 days after receiving the submission on September 23, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K213063 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 23, 2021
Decision Date	April 08, 2022
Days to Decision	197 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.