Cleared Traditional

A COMPANY BRASS SEPARATING RINGS (K851878) - FDA 510(k) Clearance

Class I Dental device.

K851878 · A Company, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1985
Decision
37d
Days
Class 1
Risk

K851878 is an FDA 510(k) clearance for the A COMPANY BRASS SEPARATING RINGS. Classified as Wire, Orthodontic (product code DZC), Class I - General Controls.

Submitted by A Company, Inc. (San Diego, US). The FDA issued a Cleared decision on June 5, 1985 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5410 - 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 A Company, Inc. devices

Submission Details

510(k) Number K851878 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1985
Decision Date June 05, 1985
Days to Decision 37 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 127d · This submission: 37d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DZC Wire, Orthodontic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.5410
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.