Cleared Traditional

DENTAL BONE SCREWS; DENTAL BONE SCREWS, CONTINUING; SCREW SYSTEM TX; SCREW SYSTEM TX PROFESSIONAL

K132212 · Hager& Meisinger GmbH · Dental
Feb 2014
Decision
213d
Days
Class 2
Risk

About This 510(k) Submission

K132212 is an FDA 510(k) clearance for the DENTAL BONE SCREWS; DENTAL BONE SCREWS, CONTINUING; SCREW SYSTEM TX; SCREW SYSTEM TX PROFESSIONAL, a Screw, Fixation, Intraosseous (Class II — Special Controls, product code DZL), submitted by Hager& Meisinger GmbH (Neuss, DE). The FDA issued a Cleared decision on February 14, 2014, 213 days after receiving the submission on July 16, 2013. This device falls under the Dental review panel. Regulated under 21 CFR 872.4880.

Submission Details

510(k) Number K132212 FDA.gov
FDA Decision Cleared SESE
Date Received July 16, 2013
Decision Date February 14, 2014
Days to Decision 213 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code DZL — Screw, Fixation, Intraosseous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4880

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