Cleared Traditional

K050354 - PERIOSCAN ULTRASONIC SCALER

K050354 is an FDA 510(k) clearance for PERIOSCAN ULTRASONIC SCALER, manufactured by Sirona Dental Systems GmbH. The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K050354 · Sirona Dental Systems GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
35d
Days
Class 2
Risk

K050354 is an FDA 510(k) clearance for the PERIOSCAN ULTRASONIC SCALER. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Sirona Dental Systems GmbH (North Attleboro, US). The FDA issued a Cleared decision on March 21, 2005 after a review of 35 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sirona Dental Systems GmbH devices

FDA 510(k) Submission Details - K050354

510(k) Number K050354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2005
Decision Date March 21, 2005
Days to Decision 35 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 127d · This submission: 35d
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 130
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K050354.
PROTEGE ULTRASONIC INSERT
K051776 · Discus Dental, Inc. · Jul 2005
SURPASSON P5 NEWTRON
K050895 · Satelec · Apr 2005
MINIMASTER ULTRASONIC SCALER
K050710 · E.M.S Electro Medical Systems S.A · Mar 2005
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K042972 · American Eagle Instruments, Inc. · Mar 2005
AZ ULTRASONIC SYSTEM
K042056 · J. Morita USA, Inc. · Sep 2004
ULTRASONIC SCALER, MODELS VARIOS 350 LUX, VARIOS 350 (NO LIGHT), VARIOS 550, VARIOS 150 LUX, VARIOS 150 (NO LIGHT)
K031421 · Nakanishi, Inc. · Mar 2004