Cleared Traditional

SURA SNAP

K924155 · Metalor Dental USA Corp. · Dental
May 1993
Decision
267d
Days
Class 2
Risk

About This 510(k) Submission

K924155 is an FDA 510(k) clearance for the SURA SNAP, a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE), submitted by Metalor Dental USA Corp. (Rockville Centre, US). The FDA issued a Cleared decision on May 12, 1993, 267 days after receiving the submission on August 18, 1992. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K924155 FDA.gov
FDA Decision Cleared SESE
Date Received August 18, 1992
Decision Date May 12, 1993
Days to Decision 267 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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