Cleared Traditional

AQUAPLAST PALATAL STENT

K973370 · Wfr/Aquaplast Corp. · Dental
Dec 1997
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K973370 is an FDA 510(k) clearance for the AQUAPLAST PALATAL STENT, a Cement, Dental (Class II — Special Controls, product code EMA), submitted by Wfr/Aquaplast Corp. (Wyckoff, US). The FDA issued a Cleared decision on December 2, 1997, 85 days after receiving the submission on September 8, 1997. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K973370 FDA.gov
FDA Decision Cleared SESE
Date Received September 08, 1997
Decision Date December 02, 1997
Days to Decision 85 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EMA — Cement, Dental
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3275