Cleared Traditional

BAR & RIDER, SCREWS, TUBES (K790078) - FDA 510(k) Clearance

Class I Dental device.

K790078 · Eurodent, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1979
Decision
48d
Days
Class 1
Risk

K790078 is an FDA 510(k) clearance for the BAR & RIDER, SCREWS, TUBES. Classified as Sterilizer, Boiling Water (product code ECG), Class I - General Controls.

Submitted by Eurodent, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 27, 1979 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6710 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Eurodent, Inc. devices

Submission Details

510(k) Number K790078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1979
Decision Date February 27, 1979
Days to Decision 48 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 127d · This submission: 48d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ECG Sterilizer, Boiling Water
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6710
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.