Cleared Traditional

Straumann? BLC and TLC Implants

K230108 · Institut Straumann AG · Dental
Sep 2023
Decision
244d
Days
Class 2
Risk

About This 510(k) Submission

K230108 is an FDA 510(k) clearance for the Straumann? BLC and TLC 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 September 14, 2023, 244 days after receiving the submission on January 13, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K230108 FDA.gov
FDA Decision Cleared SESE
Date Received January 13, 2023
Decision Date September 14, 2023
Days to Decision 244 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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