Cleared Traditional

Straumann Immediate Temporary Abutments

K201681 · Institut Straumann AG · Dental

Mar 2021

Decision

269d

Days

Class 2

Risk

About This 510(k) Submission

K201681 is an FDA 510(k) clearance for the Straumann Immediate Temporary 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 March 18, 2021, 269 days after receiving the submission on June 22, 2020. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K201681 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 22, 2020
Decision Date	March 18, 2021
Days to Decision	269 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.