Cleared Traditional

K080089 - SONICFLEX 2003 AND SONICFLEX LUX 2003 L WITH INSTRUMENT TIPS

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

K080089 · Sybron Dental Specialties, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K080089

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.

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 110
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K080089.
EMS MINIMASTER LED
K093723 · E.M.S Electro Medical Systems S.A · Sep 2010
EMS PIEZON MASTER 700
K093000 · E.M.S Electro Medical Systems S.A · Jul 2010
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
VARIOS 75
K071447 · Nakanishi, Inc. · Apr 2008
PERIOSCAN, MODEL: D 3496
K072107 · Sirona Dental Systems GmbH · Feb 2008
STERI -MATE HANDPIECE SLEEVE WITH LED LIGHT
K070307 · Dentsply International, Inc. · May 2007