Cleared Traditional

Straumann? Retentive System ? Novaloc TiN Abutments

K193046 · Institut Straumann AG · Dental

Aug 2020

Decision

286d

Days

Class 2

Risk

About This 510(k) Submission

K193046 is an FDA 510(k) clearance for the Straumann? Retentive System ? Novaloc TiN 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 August 13, 2020, 286 days after receiving the submission on November 1, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K193046 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 01, 2019
Decision Date	August 13, 2020
Days to Decision	286 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.