Cleared Traditional

PHOENIX OPTI-MAX DENT IMPLANT W/PLASMA-SPRAY TITAN

K926102 · Phoenix Dental, Inc. · Dental
Jun 1994
Decision
566d
Days
Class 2
Risk

About This 510(k) Submission

K926102 is an FDA 510(k) clearance for the PHOENIX OPTI-MAX DENT IMPLANT W/PLASMA-SPRAY TITAN, a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE), submitted by Phoenix Dental, Inc. (San Diego, US). The FDA issued a Cleared decision on June 22, 1994, 566 days after receiving the submission on December 3, 1992. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K926102 FDA.gov
FDA Decision Cleared SESE
Date Received December 03, 1992
Decision Date June 22, 1994
Days to Decision 566 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

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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