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FDA 510(k)

Straumann Mini Implants

K-Number: K191895 · 2019-12-09

ApplicantInstitut Straumann AG
Decision Date2019-12-09
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Straumann Mini Implants is a medical device manufactured by Institut Straumann AG. It received FDA 510(k) clearance on 2019-12-09 under approval number K191895. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Straumann Mini Implants?

Straumann Mini Implants is a medical device that received FDA 510(k) clearance on 2019-12-09. It is manufactured by Institut Straumann AG. The 510(k) number is K191895.

When was Straumann Mini Implants approved by the FDA?

Straumann Mini Implants received FDA 510(k) clearance on 2019-12-09, under approval number K191895.

What company makes Straumann Mini Implants?

Straumann Mini Implants is manufactured by Institut Straumann AG.

What is the FDA product code for Straumann Mini Implants?

The FDA product code for Straumann Mini Implants is DZE.

Related Clinical Trials

NCT03908177 Comparison of Clinical Performance and Safety of Zirconia vs. Titanium Implants: a Multi-national RCT. COMPLETED NCT06086873 Investigating Implant Surface Effect on Osseointegration: NGA vs. ModSLA RECRUITING

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Related Devices (Code: DZE)

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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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