Cleared Traditional

Straumann BLX Implant System

K210855 · Institut Straumann AG · Dental
Jun 2021
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K210855 is an FDA 510(k) clearance for the Straumann BLX Implant System, 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 21, 2021, 90 days after receiving the submission on March 23, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K210855 FDA.gov
FDA Decision Cleared SESE
Date Received March 23, 2021
Decision Date June 21, 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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