Cleared Traditional

Straumann? Variobase? Abutments and Straumann? n!ce? Zirconia discs

K222836 · Institut Straumann AG · Dental

May 2023

Decision

237d

Days

Class 2

Risk

About This 510(k) Submission

K222836 is an FDA 510(k) clearance for the Straumann? Variobase? Abutments and Straumann? n!ce? Zirconia discs, 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 May 15, 2023, 237 days after receiving the submission on September 20, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K222836 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 20, 2022
Decision Date	May 15, 2023
Days to Decision	237 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.