Cleared Traditional

K920328 - AMDENT 2030, POLISHER/SCALER

K920328 is an FDA 510(k) clearance for AMDENT 2030, manufactured by Amdent AB. The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 636-day FDA review.

K920328 · Amdent AB · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1993
Decision
636d
Days
Class 2
Risk

K920328 is an FDA 510(k) clearance for the AMDENT 2030, POLISHER/SCALER. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Amdent AB (Nynashamn, SE). The FDA issued a Cleared decision on October 20, 1993 after a review of 636 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4850 - 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 Amdent AB devices

FDA 510(k) Submission Details - K920328

510(k) Number K920328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1992
Decision Date October 20, 1993
Days to Decision 636 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
509d slower than avg
Panel avg: 127d · This submission: 636d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELC Device Classification - Class 2, Special Controls

Product Code ELC Scaler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - ELC Scaler, Ultrasonic

All 140
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K920328.
LE CLEAN MACHINE
K950240 · Parkell, Inc. · Apr 1995
TURBO 25/30
K950256 · Parkell, Inc. · Apr 1995
JET UNIT (CJ HANDPIECE)
K941392 · Dentsply Intl. · May 1994
INTRA-ORAL IRRIGATOR
K933547 · Parkell, Inc. · Oct 1993
THE MODEL 3003 SCALER
K930698 · Dentsply Intl. · Jul 1993
DIAMOND COATED DENTAL INSERTS
K923639 · Dentsply Intl. · Oct 1992