Cleared Traditional

Straumann CARES P-Series CAD/CAM System

K203750 · Institut Straumann AG · Dental

Oct 2021

Decision

290d

Days

Class 2

Risk

About This 510(k) Submission

K203750 is an FDA 510(k) clearance for the Straumann CARES P-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 October 9, 2021, 290 days after receiving the submission on December 23, 2020. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K203750 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 23, 2020
Decision Date	October 09, 2021
Days to Decision	290 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.