Cleared Traditional

HIGH VAC

K920492 · Hygoplastic, Inc. · Dental
May 1992
Decision
98d
Days
Class 1
Risk

About This 510(k) Submission

K920492 is an FDA 510(k) clearance for the HIGH VAC, a Mouthpiece, Saliva Ejector (Class I — General Controls, product code DYN), submitted by Hygoplastic, Inc. (Grafton, US). The FDA issued a Cleared decision on May 11, 1992, 98 days after receiving the submission on February 3, 1992. This device falls under the Dental review panel. Regulated under 21 CFR 872.6640.

Submission Details

510(k) Number K920492 FDA.gov
FDA Decision Cleared SESE
Date Received February 03, 1992
Decision Date May 11, 1992
Days to Decision 98 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code DYN — Mouthpiece, Saliva Ejector
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6640