Cleared Traditional

KLS Martin IPS Preprosthetic

K210228 · KLS-Martin L.P. · Dental
Jul 2022
Decision
526d
Days
Class 2
Risk

About This 510(k) Submission

K210228 is an FDA 510(k) clearance for the KLS Martin IPS Preprosthetic, a Implant, Subperiosteal (Class II — Special Controls, product code ELE), submitted by KLS-Martin L.P. (Jacksonville, US). The FDA issued a Cleared decision on July 8, 2022, 526 days after receiving the submission on January 28, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.3645.

Submission Details

510(k) Number K210228 FDA.gov
FDA Decision Cleared SESE
Date Received January 28, 2021
Decision Date July 08, 2022
Days to Decision 526 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code ELE — Implant, Subperiosteal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3645

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