Cleared Traditional

LEW MDI O-BALL COLLARED IMPLANT,

K121707 · Park Dental Research Corp. · Dental
Sep 2012
Decision
105d
Days
Class 2
Risk

About This 510(k) Submission

K121707 is an FDA 510(k) clearance for the LEW MDI O-BALL COLLARED IMPLANT,, a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE), submitted by Park Dental Research Corp. (Ardmore, US). The FDA issued a Cleared decision on September 24, 2012, 105 days after receiving the submission on June 11, 2012. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K121707 FDA.gov
FDA Decision Cleared SESE
Date Received June 11, 2012
Decision Date September 24, 2012
Days to Decision 105 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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