Cleared Traditional

K890529 - ALASTIGARD

K890529 is an FDA 510(k) clearance for ALASTIGARD, manufactured by Unitek Corp.. The device is a Class 1 Dental device with product code EJF cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K890529 · Unitek Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1989
Decision
35d
Days
Class 1
Risk

K890529 is an FDA 510(k) clearance for the ALASTIGARD. 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 9, 1989 after a review of 35 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

FDA 510(k) Submission Details - K890529

510(k) Number K890529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1989
Decision Date March 09, 1989
Days to Decision 35 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 127d · This submission: 35d
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 46
Devices cleared under the same product code (EJF) and FDA review panel - the closest regulatory comparables to K890529.
ORTHODONTIC ARCH AND SURGICAL HOOKS
K891592 · American Orthodontics · Apr 1989
THE CLARK LIP SHIELD
K890581 · American Orthodontics · Mar 1989
20/20 ORTHODONTIC CERAMIC BRACKET
K890145 · American Orthodontics · 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