Cleared Traditional

K923999 - ALASTIK NS

K923999 is an FDA 510(k) clearance for ALASTIK NS, manufactured by Unitek Corp.. The device is a Class 1 Dental device with product code ECI cleared through the Traditional 510(k) pathway after a 318-day FDA review.

K923999 · Unitek Corp. · Dental device
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Jun 1993
Decision
318d
Days
Class 1
Risk

K923999 is an FDA 510(k) clearance for the ALASTIK NS. Classified as Band, Elastic, Orthodontic (product code ECI), Class I - General Controls.

Submitted by Unitek Corp. (Monrovia, US). The FDA issued a Cleared decision on June 24, 1993 after a review of 318 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Unitek Corp. devices

FDA 510(k) Submission Details - K923999

510(k) Number K923999 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1992
Decision Date June 24, 1993
Days to Decision 318 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
191d slower than avg
Panel avg: 127d · This submission: 318d
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.