Cleared Traditional

K050354 - PERIOSCAN ULTRASONIC SCALER

K050354 is the FDA 510(k) clearance for PERIOSCAN ULTRASONIC SCALER by Sirona Dental Systems GmbH. It is a Class 2 Dental device (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

Submission Details

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.

Device Classification

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 58
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K050354.
ULTRASONIC SCALER, VARIOS 560
K062731 · Nakanishi, Inc. · May 2007
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K053030 · J. Morita USA, Inc. · Nov 2005
CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-131
K052334 · Dentsply Intl. · Sep 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
SIROSON L AND SIROSONIC L ULTRASONIC SCALERS
K033640 · Sirona Dental Systems GmbH · Dec 2003