Cleared Traditional

K881789 - MINILINE BRACKET

K881789 is an FDA 510(k) clearance for MINILINE BRACKET, manufactured by Alexotek Co.. The device is a Class 1 Dental device with product code EJF cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K881789 · Alexotek Co. · Dental device
Download Printable Device Report (PDF)
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Jun 1988
Decision
36d
Days
Class 1
Risk

K881789 is an FDA 510(k) clearance for the MINILINE BRACKET. Classified as Bracket, Metal, Orthodontic (product code EJF), Class I - General Controls.

Submitted by Alexotek Co. (Eugene, US). The FDA issued a Cleared decision on June 1, 1988 after a review of 36 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 Alexotek Co. devices

FDA 510(k) Submission Details - K881789

510(k) Number K881789 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1988
Decision Date June 01, 1988
Days to Decision 36 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 128d · This submission: 36d
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 K881789.
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