Cleared Traditional

K922806 - ORMCO SPORTSGUARD

K922806 is an FDA 510(k) clearance for ORMCO SPORTSGUARD, 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 497-day FDA review.

K922806 · Ormco Corp. · Dental device
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Oct 1993
Decision
497d
Days
Class 1
Risk

K922806 is an FDA 510(k) clearance for the ORMCO SPORTSGUARD. 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 October 20, 1993 after a review of 497 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

FDA 510(k) Submission Details - K922806

510(k) Number K922806 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1992
Decision Date October 20, 1993
Days to Decision 497 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
369d slower than avg
Panel avg: 128d · This submission: 497d
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 K922806.
LARIAT PALATE EXPANDER
K926427 · Easy Access Orthodontics, Inc. · Jan 1994
CHANNEL-EDGE BRACKET SYSTEM
K930881 · Dualtek, Inc. · Jan 1994
REGENCY PLUS BRACKET
K933758 · Mid-American Dental Specialties, Inc. · Jan 1994
NITANIUM PALATAL EXPANDER
K923218 · Ortho Organizers, Inc. · Sep 1993
PLASTIC CHAIN
K925012 · American Orthodontics · Sep 1993
ION-IMPLANTED NEO SENTALLOY
K932025 · Gac Intl., Inc. · Sep 1993
K922806 · ORMCO SPORTSGUARD
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