Cleared Traditional

K033044 - DREAM CLEANSE S SCALER, DREAM COMPACT S SCALER

K033044 is an FDA 510(k) clearance for DREAM CLEANSE S SCALER, manufactured by American Green Dent. Mfg, Inc.. The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 449-day FDA review.

K033044 · American Green Dent. Mfg, Inc. · Dental device
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Dec 2004
Decision
449d
Days
Class 2
Risk

K033044 is an FDA 510(k) clearance for the DREAM CLEANSE S SCALER, DREAM COMPACT S SCALER. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by American Green Dent. Mfg, Inc. (Los Angeles, US). The FDA issued a Cleared decision on December 21, 2004 after a review of 449 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.

FDA 510(k) Submission Details - K033044

510(k) Number K033044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2003
Decision Date December 21, 2004
Days to Decision 449 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
321d slower than avg
Panel avg: 128d · This submission: 449d
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 187
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K033044.
MINIMASTER ULTRASONIC SCALER
K050710 · E.M.S Electro Medical Systems S.A · Mar 2005
PERIOSCAN ULTRASONIC SCALER
K050354 · Sirona Dental Systems GmbH · Mar 2005
XP TECHNOLOGY ULTRASONIC SCALER
K042972 · American Eagle Instruments, Inc. · Mar 2005
AZ ULTRASONIC SYSTEM
K042056 · J. Morita USA, Inc. · Sep 2004
APOZA ULTRASONIC SCALER AND EDODONTICS UNIT, SELECTOR U2
K033198 · Apoza Enterprise Co., Ltd. · Apr 2004
ULTRASONIC SCALER ELEGANCE MS-10 (25K)
K040396 · Rolence Enteprise, Inc. · Apr 2004
K033044 · DREAM CLEANSE S SCALER, DREAM COMPACT S SCALER
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