Cleared Traditional

K925115 - AMD DENTIST AND HYGIENIST KITS (FDA 510(k) Clearance)

Class I Dental device.

K925115 · Advance Medical Designs, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
634d
Days
Class 1
Risk

K925115 is an FDA 510(k) clearance for the AMD DENTIST AND HYGIENIST KITS. Classified as Burnisher, Operative (product code EKJ), Class I - General Controls.

Submitted by Advance Medical Designs, Inc. (Marietta, US). The FDA issued a Cleared decision on July 5, 1994 after a review of 634 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4565 - 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 Advance Medical Designs, Inc. devices

Submission Details

510(k) Number K925115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1992
Decision Date July 05, 1994
Days to Decision 634 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
507d slower than avg
Panel avg: 127d · This submission: 634d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EKJ Burnisher, Operative
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4565
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.