Cleared Traditional

FORESTADENT ORTHODONTIC BANDS (K925028) - FDA 510(k) Clearance

Class I Dental device.

K925028 · Forestadent · Dental device
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Jan 1994
Decision
481d
Days
Class 1
Risk

K925028 is an FDA 510(k) clearance for the FORESTADENT ORTHODONTIC BANDS. Classified as Bracket, Metal, Orthodontic (product code EJF), Class I - General Controls.

Submitted by Forestadent (Germany, DE). The FDA issued a Cleared decision on January 26, 1994 after a review of 481 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Forestadent devices

Submission Details

510(k) Number K925028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1992
Decision Date January 26, 1994
Days to Decision 481 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
354d slower than avg
Panel avg: 127d · This submission: 481d
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.