Cleared Traditional

Straumann? RidgeFit Implants

K250294 · Institut Straumann AG · Dental
Aug 2025
Decision
193d
Days
Class 2
Risk

About This 510(k) Submission

K250294 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 August 12, 2025, 193 days after receiving the submission on January 31, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K250294 FDA.gov
FDA Decision Cleared SESE
Date Received January 31, 2025
Decision Date August 12, 2025
Days to Decision 193 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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