Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Straumann CARES Screw-Retained Bridges and Bars

K-Number: K190097 · 2019-06-26

ApplicantInstitut Straumann AG
Decision Date2019-06-26
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Straumann CARES Screw-Retained Bridges and Bars is the device name listed in this FDA 510(k) record. The listed applicant is Institut Straumann AG. It received FDA 510(k) clearance on 2019-06-26 under 510(k) number K190097. 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 Straumann CARES Screw-Retained Bridges and Bars?

Straumann CARES Screw-Retained Bridges and Bars is a medical device that received FDA 510(k) clearance on 2019-06-26. The listed applicant is Institut Straumann AG. The 510(k) number is K190097.

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

Straumann CARES Screw-Retained Bridges and Bars received FDA 510(k) clearance on 2019-06-26, under 510(k) number K190097.

Who is the listed applicant for Straumann CARES Screw-Retained Bridges and Bars?

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

What is the FDA product code for Straumann CARES Screw-Retained Bridges and Bars?

The FDA product code for Straumann CARES Screw-Retained Bridges and Bars is NHA.

Other records listing Institut Straumann AG as applicant

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.

K260726Straumann® ProClean™ Cassette (041.800 ; 041.801)K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueK252168Straumann® BLC Implants - Indication WideningK253315Straumann Variobase Abutments XC for Bridge/BarK250294Straumann® RidgeFit ImplantsK243278Custom Abutments

View all 57 devices →

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.

↑