Cleared Traditional

Straumann? PURE Ceramic Implants

K241391 · Institut Straumann AG · Dental
Dec 2024
Decision
209d
Days
Class 2
Risk

About This 510(k) Submission

K241391 is an FDA 510(k) clearance for the Straumann? PURE Ceramic 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 December 10, 2024, 209 days after receiving the submission on May 15, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K241391 FDA.gov
FDA Decision Cleared SESE
Date Received May 15, 2024
Decision Date December 10, 2024
Days to Decision 209 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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