Cleared Traditional

K891484 - ORTHODONTIC WRAP-AROUND HAWLEY RETAINER

K891484 is the FDA 510(k) clearance for ORTHODONTIC WRAP-AROUND HAWLEY RETAINER by American Orthodontics. It is a Class 1 Dental device (product code EJF) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K891484 · American Orthodontics · Dental device

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Apr 1989

Decision

28d

Days

Class 1

Risk

K891484 is an FDA 510(k) clearance for the ORTHODONTIC WRAP-AROUND HAWLEY RETAINER. Classified as Bracket, Metal, Orthodontic (product code EJF), Class I - General Controls.

Submitted by American Orthodontics (Sheboygan, US). The FDA issued a Cleared decision on April 14, 1989 after a review of 28 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 American Orthodontics devices

Submission Details

510(k) Number	K891484 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 17, 1989
Decision Date	April 14, 1989
Days to Decision	28 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

99d faster than avg

Panel avg: 127d · This submission: 28d

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 30

Devices cleared under the same product code (EJF) and FDA review panel - the closest regulatory comparables to K891484.

FILAFLEX ORTHODONTIC WIRE

K891599 · American Orthodontics · May 1989

JASPER JUMPER KIT

K890536 · American Orthodontics · May 1989

LIP BUMPER

K890656 · American Orthodontics · Apr 1989

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

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K891484

American Orthodontics

Sheboygan, WI · US

PAUL RIDDLE

Regulatory profile

45 submissions 45 cleared

100% clearance rate · Active in Dental

Data Intelligence Layer

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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