Cleared Traditional

BAR & RIDER, SCREWS, TUBES

K790078 · Eurodent, Inc. · Dental
Feb 1979
Decision
48d
Days
Class 1
Risk

About This 510(k) Submission

K790078 is an FDA 510(k) clearance for the BAR & RIDER, SCREWS, TUBES, a Sterilizer, Boiling Water (Class I — General Controls, product code ECG), submitted by Eurodent, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 27, 1979, 48 days after receiving the submission on January 10, 1979. This device falls under the Dental review panel. Regulated under 21 CFR 872.6710.

Submission Details

510(k) Number K790078 FDA.gov
FDA Decision Cleared SESE
Date Received January 10, 1979
Decision Date February 27, 1979
Days to Decision 48 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code ECG — Sterilizer, Boiling Water
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6710