Cleared Special

K203456 - Straumann CARES M-Series CAD/CAM System

K203456 is an FDA 510(k) clearance for Straumann CARES M-Series CAD/CAM System, manufactured by Institut Straumann AG. The device is a Class 2 Dental device with product code NHA cleared through the Special 510(k) pathway after a 212-day FDA review.

K203456 · Institut Straumann AG · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2021
Decision
212d
Days
Class 2
Risk

K203456 is an FDA 510(k) clearance for the Straumann CARES M-Series CAD/CAM System. Classified as Abutment, Implant, Dental, Endosseous within the NHA classification (a category for dental implant abutments and prosthetic components), Class II - Special Controls.

Submitted by Institut Straumann AG (Basel, CH). The FDA issued a Cleared decision on June 23, 2021 after a review of 212 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3630 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K203456

510(k) Number K203456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d slower than avg
Panel avg: 128d · This submission: 212d
Pathway characteristics
Modification to existing cleared device.

NHA Device Classification - Class 2, Special Controls

Product Code NHA Abutment, Implant, Dental, Endosseous
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Consultant

Straumann USA, LLC
Jennifer M Jackson

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NHA Abutment, Implant, Dental, Endosseous

All 715
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K203456.
MIS Ti-base abutment
K211225 · Dentsply Sirona · Jul 2021
IS Multi Unit Abutment System
K210903 · Neobiotech Co., Ltd. · Jul 2021
TruAbutment DS, TruBase
K202579 · Truabutment, Inc. · Jul 2021
TruBase S
K201842 · Truabutment, Inc. · Jun 2021
AccelX Abutments
K203240 · Integrated Dental Systems, LLC · Apr 2021
CreoDent Solidex Customized Abutment
K202909 · Creodent Prosthetics, Ltd. · Apr 2021
K203456 · Straumann CARES M-Series CAD/CAM System
Download PDF FDA Summary Institut Straumann AG