Cleared Traditional

K072107 - PERIOSCAN

K072107 is the FDA 510(k) clearance for PERIOSCAN by Sirona Dental Systems GmbH. It is a Class 2 Dental device (product code ELC) cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K072107 · Sirona Dental Systems GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2008
Decision
198d
Days
Class 2
Risk

K072107 is an FDA 510(k) clearance for the PERIOSCAN, MODEL: D 3496. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Sirona Dental Systems GmbH (Bensheim, DE). The FDA issued a Cleared decision on February 14, 2008 after a review of 198 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Sirona Dental Systems GmbH devices

Submission Details

510(k) Number K072107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2007
Decision Date February 14, 2008
Days to Decision 198 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
71d slower than avg
Panel avg: 127d · This submission: 198d
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 K072107.
A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM
K100647 · A-Dec, Inc. · Jul 2010
SONICFLEX 2003 AND SONICFLEX LUX 2003 L WITH INSTRUMENT TIPS
K080089 · Sybron Dental Specialties, Inc. · Sep 2008
VARIOS 75
K071447 · Nakanishi, Inc. · Apr 2008
STERI -MATE HANDPIECE SLEEVE WITH LED LIGHT
K070307 · Dentsply International, Inc. · May 2007
ULTRASONIC SCALER, VARIOS 560
K062731 · Nakanishi, Inc. · May 2007
J. MORITA AZ ULTRASONIC SYSTEM
K053030 · J. Morita USA, Inc. · Nov 2005