Cleared Traditional

MINIDAM

K921117 · Delsan Dental Systems · Dental
May 1992
Decision
57d
Days
Class 1
Risk

About This 510(k) Submission

K921117 is an FDA 510(k) clearance for the MINIDAM, a Mouthpiece, Saliva Ejector (Class I — General Controls, product code DYN), submitted by Delsan Dental Systems (Pennington, US). The FDA issued a Cleared decision on May 5, 1992, 57 days after receiving the submission on March 9, 1992. This device falls under the Dental review panel. Regulated under 21 CFR 872.6640.

Submission Details

510(k) Number K921117 FDA.gov
FDA Decision Cleared SESE
Date Received March 09, 1992
Decision Date May 05, 1992
Days to Decision 57 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