Cleared Traditional

BLX WB ?5.0 (L18), ?5.5 and ?6.5 mm (L14 and L16) Implants

K212533 · Institut Straumann AG · Dental
Jan 2022
Decision
170d
Days
Class 2
Risk

About This 510(k) Submission

K212533 is an FDA 510(k) clearance for the BLX WB ?5.0 (L18), ?5.5 and ?6.5 mm (L14 and L16) 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 January 28, 2022, 170 days after receiving the submission on August 11, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K212533 FDA.gov
FDA Decision Cleared SESE
Date Received August 11, 2021
Decision Date January 28, 2022
Days to Decision 170 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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