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FDA 510(k)

CARES Screw - Retained Bars and Bridges (SRBB)

K-Number: K201711 · 2020-12-08

ApplicantMedentika GmbH
Decision Date2020-12-08
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CARES Screw - Retained Bars and Bridges (SRBB) is the device name listed in this FDA 510(k) record. The listed applicant is Medentika GmbH. It received FDA 510(k) clearance on 2020-12-08 under 510(k) number K201711. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARES Screw - Retained Bars and Bridges (SRBB)?

CARES Screw - Retained Bars and Bridges (SRBB) is a medical device that received FDA 510(k) clearance on 2020-12-08. The listed applicant is Medentika GmbH. The 510(k) number is K201711.

When did CARES Screw - Retained Bars and Bridges (SRBB) receive FDA 510(k) clearance?

CARES Screw - Retained Bars and Bridges (SRBB) received FDA 510(k) clearance on 2020-12-08, under 510(k) number K201711.

Who is the listed applicant for CARES Screw - Retained Bars and Bridges (SRBB)?

The FDA 510(k) record lists Medentika GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARES Screw - Retained Bars and Bridges (SRBB)?

The FDA product code for CARES Screw - Retained Bars and Bridges (SRBB) is NHA.

Other records listing Medentika GmbH as applicant

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K253341Custom Abutments ASK242542Medentika CAD/CAM AbutmentsK223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit AbutmentsK200906MINICONE ImplantK191123Multi-unit AbutmentsK180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases

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Related Devices (Code: NHA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic ScrewNobel Biocare ABK261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLCK260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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