Cleared Traditional

K080089 - SONICFLEX 2003 AND SONICFLEX LUX 2003 L...

K080089 is the FDA 510(k) clearance for SONICFLEX 2003 AND SONICFLEX LUX 2003 L... by Sybron Dental Specialties, Inc.. It is a Class 2 Dental device (product code ELC) cleared through the Traditional 510(k) pathway after a 234-day FDA review.

K080089 · Sybron Dental Specialties, Inc. · Dental device
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Sep 2008
Decision
234d
Days
Class 2
Risk

K080089 is an FDA 510(k) clearance for the SONICFLEX 2003 AND SONICFLEX LUX 2003 L WITH INSTRUMENT TIPS. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Sybron Dental Specialties, Inc. (Orange, US). The FDA issued a Cleared decision on September 4, 2008 after a review of 234 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 Sybron Dental Specialties, Inc. devices

Submission Details

510(k) Number K080089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2008
Decision Date September 04, 2008
Days to Decision 234 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
107d slower than avg
Panel avg: 127d · This submission: 234d
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 45
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