Cleared Traditional

K914616 - KLEER(TM) ORTHODONTIC BRACKET

K914616 is an FDA 510(k) clearance for KLEER(TM) ORTHODONTIC BRACKET, manufactured by Ormco Corp.. The device is a Class 1 Dental device with product code EJF cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K914616 · Ormco Corp. · Dental device

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Nov 1991

Decision

34d

Days

Class 1

Risk

K914616 is an FDA 510(k) clearance for the KLEER(TM) ORTHODONTIC BRACKET. Classified as Bracket, Metal, Orthodontic (product code EJF), Class I - General Controls.

Submitted by Ormco Corp. (Glendora, US). The FDA issued a Cleared decision on November 20, 1991 after a review of 34 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.

FDA 510(k) Submission Details - K914616

510(k) Number	K914616 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 17, 1991
Decision Date	November 20, 1991
Days to Decision	34 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

94d faster than avg

Panel avg: 128d · This submission: 34d

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 88

Devices cleared under the same product code (EJF) and FDA review panel - the closest regulatory comparables to K914616.

ORTHODONTIC ELASTICS BANDS

K920645 · Masel Industries, Inc. · Jul 1992

MIDAS BRACKET

K914003 · Gold'N Braces, Inc. · Dec 1991

REFURBISHED ORTHODONTIC APPLIANCES

K913913 · Ortho-Cycle Co. · Nov 1991

ORTHODONTIC WIRE

K911231 · Masel Industries, Inc. · Oct 1991

PREDISPENSED ORTHODONTIC CERAMIC BRACKET ADHESIVE

K912171 · Jack James · Aug 1991

NONSTAINING ALASTIKS

K910288 · Unitek Corp. · Mar 1991

FDA 510(k) Resources - Dental

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

Manufacturer of K914616

Ormco Corp.

Glendora, CA · US

FRANCES ZEE

Regulatory profile

40 submissions 39 cleared

98% clearance rate · Active in Dental

View all devices by Ormco Corp. →

About This 510(k) Record

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 . FDA decision: November 20, 1991. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: August 2026.

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