Cleared Traditional

K900578 - SPORTS PACK ELASTICS

K900578 is the FDA 510(k) clearance for SPORTS PACK ELASTICS by Lancer Orthodontics, Inc.. It is a Class 1 Dental device (product code EJF) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K900578 · Lancer Orthodontics, Inc. · Dental device
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Apr 1990
Decision
62d
Days
Class 1
Risk

K900578 is an FDA 510(k) clearance for the SPORTS PACK ELASTICS. Classified as Bracket, Metal, Orthodontic (product code EJF), Class I - General Controls.

Submitted by Lancer Orthodontics, Inc. (Carlsbad, US). The FDA issued a Cleared decision on April 10, 1990 after a review of 62 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 Lancer Orthodontics, Inc. devices

Submission Details

510(k) Number K900578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1990
Decision Date April 10, 1990
Days to Decision 62 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 127d · This submission: 62d
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 23
Devices cleared under the same product code (EJF) and FDA review panel - the closest regulatory comparables to K900578.
MODIFIED UNI-STICK PLASTIC LIGATURE
K902064 · American Orthodontics · Aug 1990
MODIFIED X-RING AND SPEED STIX PLASTICE LIGATURE
K900488 · American Orthodontics · Jun 1990
STAINLESS STEEL DENTAL WIRES AND CLASPS
K901024 · Ivoclar North America, Inc. · Apr 1990
UNI-STICK PLASTIC LIGATURES
K891331 · American Orthodontics · Oct 1989
KORN MANDIBULAR ADVANCER
K893482 · American Orthodontics · Oct 1989
KOBAYASHI HOOK AND TWIST KOBAYASHI HOOK
K893655 · American Orthodontics · Aug 1989