Cleared Traditional

K900488 - MODIFIED X-RING AND SPEED STIX PLASTICE LIGATURE

K900488 is an FDA 510(k) clearance for MODIFIED X-RING AND SPEED STIX PLASTICE..., manufactured by American Orthodontics. The device is a Class 1 Dental device with product code EJF cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K900488 · American Orthodontics · Dental device
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Jun 1990
Decision
122d
Days
Class 1
Risk

K900488 is an FDA 510(k) clearance for the MODIFIED X-RING AND SPEED STIX PLASTICE LIGATURE. 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 June 1, 1990 after a review of 122 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K900488

510(k) Number K900488 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1990
Decision Date June 01, 1990
Days to Decision 122 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
6d faster than avg
Panel avg: 128d · This submission: 122d
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 102
Devices cleared under the same product code (EJF) and FDA review panel - the closest regulatory comparables to K900488.
BIOLASTIC SUPER ELASTIC ARCHES
K902050 · Rmo, Inc. · Aug 1990
FIBERBRAID(TM) BONDED RETAINER
K900471 · Uthoff Dental Mfg. · Aug 1990
MUSTANG, C.A.T.
K901957 · Lancer Orthodontics, Inc. · Jul 1990
FLUOR-I-CHAINS(TM) AND FLUOR-I-TIES(TM)
K900824 · Midwest Orthodontic Mfg. · May 1990
STAINLESS STEEL DENTAL WIRES AND CLASPS
K901024 · Ivoclar North America, Inc. · Apr 1990
SPORTS PACK ELASTICS
K900578 · Lancer Orthodontics, Inc. · Apr 1990
K900488 · MODIFIED X-RING AND SPEED STIX PLASTICE LIGATURE
Download PDF American Orthodontics