Cleared Traditional

SUPER SEAL

K983477 · Phoenix Dental, Inc. · Dental
Dec 1998
Decision
81d
Days
Class 2
Risk

About This 510(k) Submission

K983477 is an FDA 510(k) clearance for the SUPER SEAL, a Liner, Cavity, Calcium Hydroxide (Class II — Special Controls, product code EJK), submitted by Phoenix Dental, Inc. (Fenton, US). The FDA issued a Cleared decision on December 22, 1998, 81 days after receiving the submission on October 2, 1998. This device falls under the Dental review panel. Regulated under 21 CFR 872.3250.

Submission Details

510(k) Number K983477 FDA.gov
FDA Decision Cleared SESE
Date Received October 02, 1998
Decision Date December 22, 1998
Days to Decision 81 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EJK — Liner, Cavity, Calcium Hydroxide
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3250

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