Cleared Traditional

K072107 - PERIOSCAN, MODEL: D 3496

K072107 is an FDA 510(k) clearance for PERIOSCAN, 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 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

FDA 510(k) Submission Details - K072107

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.

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 K072107.
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VARIOS 75
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ULTRASONIC SCALER, VARIOS 560
K062731 · Nakanishi, Inc. · May 2007