Cleared Traditional

Straumann RidgeFit Implants

K211052 · Institut Straumann AG · Dental
Jul 2021
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K211052 is an FDA 510(k) clearance for the Straumann RidgeFit Implants, a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE), submitted by Institut Straumann AG (Basel, CH). The FDA issued a Cleared decision on July 8, 2021, 90 days after receiving the submission on April 9, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K211052 FDA.gov
FDA Decision Cleared SESE
Date Received April 09, 2021
Decision Date July 08, 2021
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code DZE — Implant, Endosseous, Root-form
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3640

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