Cleared Traditional

Straumann SLActive labeling changes

K223083 · Institut Straumann AG · Dental
Jun 2023
Decision
265d
Days
Class 2
Risk

About This 510(k) Submission

K223083 is an FDA 510(k) clearance for the Straumann SLActive labeling changes, 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 June 22, 2023, 265 days after receiving the submission on September 30, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K223083 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2022
Decision Date June 22, 2023
Days to Decision 265 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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