Cleared Traditional

PURE Ceramic Implants

K151328 · Straumann USA · Dental
Jan 2016
Decision
238d
Days
Class 2
Risk

About This 510(k) Submission

K151328 is an FDA 510(k) clearance for the PURE Ceramic Implants, a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE), submitted by Straumann USA (Andover, US). The FDA issued a Cleared decision on January 11, 2016, 238 days after receiving the submission on May 18, 2015. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K151328 FDA.gov
FDA Decision Cleared SESE
Date Received May 18, 2015
Decision Date January 11, 2016
Days to Decision 238 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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