Cleared Special

Straumann CARES M-Series CAD/CAM System

K203456 · Institut Straumann AG · Dental

Jun 2021

Decision

212d

Days

Class 2

Risk

About This 510(k) Submission

K203456 is an FDA 510(k) clearance for the Straumann CARES M-Series CAD/CAM System, 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 June 23, 2021, 212 days after receiving the submission on November 23, 2020. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K203456 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 23, 2020
Decision Date	June 23, 2021
Days to Decision	212 days
Submission Type	Special
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.