Cleared Traditional

AMD DENTIST AND HYGIENIST KITS (K925115) - 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.

Regulatory Peers - EKJ Burnisher, Operative

All 71
Devices cleared under the same product code (EKJ) and FDA review panel - the closest regulatory comparables to K925115.
SUREFLEX FILES
K951607 · Dentsply Intl. · Jun 1995
PRESTERILIZED ENDODONTIC FILES
K943584 · Dentsply Intl. · Sep 1994
VITRABOND LIGHT CURE GLASS IONOMER LINER
K882821 · 3M Company · Sep 1988
DENTALVISION TV SYSTEM
K880542 · Dentsply Intl. · May 1988
DISPOSABLE DENTAL PROBE/EXPLORER
K880590 · Baxter Healthcare Corp · Mar 1988