Cleared Traditional

K910288 - NONSTAINING ALASTIKS

K910288 is the FDA 510(k) clearance for NONSTAINING ALASTIKS by Unitek Corp.. It is a Class 1 Dental device (product code EJF) cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K910288 · Unitek Corp. · Dental device
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Mar 1991
Decision
66d
Days
Class 1
Risk

K910288 is an FDA 510(k) clearance for the NONSTAINING ALASTIKS. Classified as Bracket, Metal, Orthodontic (product code EJF), Class I - General Controls.

Submitted by Unitek Corp. (Monrovia, US). The FDA issued a Cleared decision on March 29, 1991 after a review of 66 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 Unitek Corp. devices

Submission Details

510(k) Number K910288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1991
Decision Date March 29, 1991
Days to Decision 66 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 127d · This submission: 66d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 31
Devices cleared under the same product code (EJF) and FDA review panel - the closest regulatory comparables to K910288.
THE HERBST APPLIANCE
K923405 · Ormco Corp. · May 1993
ORTHODONTIC METAL BRACKET
K923261 · American Orthodontics · Dec 1992
KLEER(TM) ORTHODONTIC BRACKET
K914616 · Ormco Corp. · Nov 1991
MODIFIED UNI-STICK PLASTIC LIGATURE
K902064 · American Orthodontics · Aug 1990
MODIFIED X-RING AND SPEED STIX PLASTICE LIGATURE
K900488 · American Orthodontics · Jun 1990
STAINLESS STEEL DENTAL WIRES AND CLASPS
K901024 · Ivoclar North America, Inc. · Apr 1990