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 BoneCeramic

K-Number: K201051 · 2020-09-24

ApplicantInstitut Straumann AG
Decision Date2020-09-24
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Straumann BoneCeramic 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 2020-09-24 under 510(k) number K201051. The device is classified under product code LYC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Straumann BoneCeramic?

Straumann BoneCeramic is a medical device that received FDA 510(k) clearance on 2020-09-24. The listed applicant is Institut Straumann AG. The 510(k) number is K201051.

When did Straumann BoneCeramic receive FDA 510(k) clearance?

Straumann BoneCeramic received FDA 510(k) clearance on 2020-09-24, under 510(k) number K201051.

Who is the listed applicant for Straumann BoneCeramic?

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 BoneCeramic?

The FDA product code for Straumann BoneCeramic is LYC.

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: LYC)

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.

K253317Cytrans™ ElashieldGC America, Inc.K253883Bonalive MaxillofacialBonalive , Ltd.K251818BONTREE PLUSHudens Bio Co., Ltd.K244006FG Bone Graft MFull Golden Biotech Co., Ltd.K243745FG Bone Graft BFull Golden Biotech CorporationK241186Synthetic Bone Graft ParticulateShenzhen Dazhou Medical Technology Co., Ltd.

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.

↑