Cleared Traditional

Straumann? BLC Implants - Indication Widening

K252168 · Institut Straumann AG · Dental
Mar 2026
Decision
243d
Days
Class 2
Risk

About This 510(k) Submission

K252168 is an FDA 510(k) clearance for the Straumann? BLC Implants - Indication Widening, 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 March 10, 2026, 243 days after receiving the submission on July 10, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K252168 FDA.gov
FDA Decision Cleared SESE
Date Received July 10, 2025
Decision Date March 10, 2026
Days to Decision 243 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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