Cleared Traditional

K874396 - OCO PREPARATIONS

K874396 is an FDA 510(k) clearance for OCO PREPARATIONS, manufactured by Williams Importing Company, Inc.. The device is a Class 1 Dental device with product code EJF cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K874396 · Williams Importing Company, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1988
Decision
203d
Days
Class 1
Risk

K874396 is an FDA 510(k) clearance for the OCO PREPARATIONS. Classified as Bracket, Metal, Orthodontic (product code EJF), Class I - General Controls.

Submitted by Williams Importing Company, Inc. (Hampton, US). The FDA issued a Cleared decision on May 18, 1988 after a review of 203 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Williams Importing Company, Inc. devices

FDA 510(k) Submission Details - K874396

510(k) Number K874396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1987
Decision Date May 18, 1988
Days to Decision 203 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 128d · This submission: 203d
Pathway characteristics
Predicate-based equivalence.

EJF Device Classification - Class 1, General Controls

Product Code EJF Bracket, Metal, 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.

Regulatory Peers - EJF Bracket, Metal, Orthodontic

All 47
Devices cleared under the same product code (EJF) and FDA review panel - the closest regulatory comparables to K874396.
ALASTIGARD
K890529 · Unitek Corp. · Mar 1989
TIN COATED NITI ORTHODONTIC ARCH WIRES
K885086 · Flexmedics · Jan 1989
FLEX PLASTIC PLASTIC COATED NITINOL ARCH WIRE
K883120 · Flexmedics · Nov 1988
STRAIGHT LENGTH ARCH WIRES
K881233 · Flexmedics · Apr 1988
CENTER BEND ARCH WIRES
K881274 · Flexmedics · Apr 1988
REVERSE CURVE ARCHWIRE
K880882 · Flexmedics · Apr 1988