Cleared Traditional

INNO SLA SUBMERGED IMPLANT SYSTEM

K132242 · Cowellmedi Co., Ltd. · Dental
Dec 2013
Decision
141d
Days
Class 2
Risk

About This 510(k) Submission

K132242 is an FDA 510(k) clearance for the INNO SLA SUBMERGED IMPLANT SYSTEM, a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE), submitted by Cowellmedi Co., Ltd. (Brea, US). The FDA issued a Cleared decision on December 6, 2013, 141 days after receiving the submission on July 18, 2013. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K132242 FDA.gov
FDA Decision Cleared SESE
Date Received July 18, 2013
Decision Date December 06, 2013
Days to Decision 141 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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