Cleared Traditional

K932298 - PRO'S NEO-LASTICS

K932298 is an FDA 510(k) clearance for PRO'S NEO-LASTICS, manufactured by Professional Positioners, Inc.. The device is a Class 1 Dental device with product code ECI cleared through the Traditional 510(k) pathway after a 279-day FDA review.

K932298 · Professional Positioners, Inc. · Dental device
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Feb 1994
Decision
279d
Days
Class 1
Risk

K932298 is an FDA 510(k) clearance for the PRO'S NEO-LASTICS. Classified as Band, Elastic, Orthodontic (product code ECI), Class I - General Controls.

Submitted by Professional Positioners, Inc. (Racine, US). The FDA issued a Cleared decision on February 14, 1994 after a review of 279 days - an extended review 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: 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.

View all Professional Positioners, Inc. devices

FDA 510(k) Submission Details - K932298

510(k) Number K932298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1993
Decision Date February 14, 1994
Days to Decision 279 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
152d slower than avg
Panel avg: 127d · This submission: 279d
Pathway characteristics
Predicate-based equivalence.

ECI Device Classification - Class 1, General Controls

Product Code ECI Band, Elastic, 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 - ECI Band, Elastic, Orthodontic

All 7
Devices cleared under the same product code (ECI) and FDA review panel - the closest regulatory comparables to K932298.
GLENROE CHAIN
K980053 · Glenroe Technologies · Feb 1998
GLENROE GLOW IN DARK ELASTOMERIC LIGATURES
K973495 · Glenroe · Dec 1997
ALASTIK
K940165 · Unitek Corp. · Mar 1994
DENTAURUM OLYMPIA LATEX-ELASTICS AND DENTAURUM LATEX-ELASTICS
K935144 · Dentauraum, Inc. · Feb 1994
ALASTIK NS
K923999 · Unitek Corp. · Jun 1993
UNI-STICK PLASTIC LIGATURE, MODIFIED
K926578 · American Orthodontics · Mar 1993