Cleared Traditional

K902050 - BIOLASTIC SUPER ELASTIC ARCHES

K902050 is an FDA 510(k) clearance for BIOLASTIC SUPER ELASTIC ARCHES, manufactured by Rmo, Inc.. The device is a Class 1 Dental device with product code EJF cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K902050 · Rmo, Inc. · Dental device
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Aug 1990
Decision
88d
Days
Class 1
Risk

K902050 is an FDA 510(k) clearance for the BIOLASTIC SUPER ELASTIC ARCHES. Classified as Bracket, Metal, Orthodontic (product code EJF), Class I - General Controls.

Submitted by Rmo, Inc. (Denver, US). The FDA issued a Cleared decision on August 3, 1990 after a review of 88 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 Rmo, Inc. devices

FDA 510(k) Submission Details - K902050

510(k) Number K902050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1990
Decision Date August 03, 1990
Days to Decision 88 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 127d · This submission: 88d
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 47
Devices cleared under the same product code (EJF) and FDA review panel - the closest regulatory comparables to K902050.
NONSTAINING ALASTIKS
K910288 · Unitek Corp. · Mar 1991
ENDOMETRIAL SAMPLER
K901896 · Kirwan Surgical Products, Inc. · Aug 1990
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
LINGUAL SHEATH
K900184 · Ormco Corp. · Apr 1990