Cleared Traditional

K800395 - ARISTOSURG 250

K800395 is an FDA 510(k) clearance for ARISTOSURG 250, manufactured by Halmon-Locren, Inc.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K800395 · Halmon-Locren, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1980
Decision
20d
Days
Class 1
Risk

K800395 is an FDA 510(k) clearance for the ARISTOSURG 250. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Halmon-Locren, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 17, 1980 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - 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 Halmon-Locren, Inc. devices

FDA 510(k) Submission Details - K800395

510(k) Number K800395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1980
Decision Date March 17, 1980
Days to Decision 20 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 128d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

EIA Device Classification - Class 1, General Controls

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
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.