Cleared Traditional

BITEM LOCK, MODELS SW006, SW012 (K994357) - FDA 510(k) Clearance

Class I Dental device.

K994357 · Thermoelastic Technologies, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2000
Decision
78d
Days
Class 1
Risk

K994357 is an FDA 510(k) clearance for the BITEM LOCK, MODELS SW006, SW012. Classified as Bracket, Metal, Orthodontic (product code EJF), Class I - General Controls.

Submitted by Thermoelastic Technologies, Inc. (New Port Riche, US). The FDA issued a Cleared decision on March 14, 2000 after a review of 78 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 Thermoelastic Technologies, Inc. devices

Submission Details

510(k) Number K994357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1999
Decision Date March 14, 2000
Days to Decision 78 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 127d · This submission: 78d
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.