Cleared Traditional

K051933 - EXPASYL POWER APPLICATOR

K051933 is an FDA 510(k) clearance for EXPASYL POWER APPLICATOR, manufactured by Sybron Dental Specialties, Inc.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K051933 · Sybron Dental Specialties, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2006
Decision
174d
Days
Class 2
Risk

K051933 is an FDA 510(k) clearance for the EXPASYL POWER APPLICATOR. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Sybron Dental Specialties, Inc. (Orange, US). The FDA issued a Cleared decision on January 3, 2006 after a review of 174 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - 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 - K051933

510(k) Number K051933 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2005
Decision Date January 03, 2006
Days to Decision 174 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
47d slower than avg
Panel avg: 127d · This submission: 174d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELW Device Classification - Class 2, Special Controls

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
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 - ELW Material, Impression

All 296
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K051933.
SIMULATE, COLOR CHANGE ALGINATE
K061267 · Cavex Holland BV · Jul 2006
PRE-IMPRESSION CONDITIONING SOLUTION
K061427 · Dentsply Intl. · Jun 2006
COLORBITE
K053619 · Zhermack S.P.A. · Mar 2006
IMPRESSIX
K052455 · Cavex Holland BV · Nov 2005
FUTURE WASH/YPS
K051797 · 3M Espe AG Dental Products · Jul 2005
ELITE IMPLANT
K050417 · Zhermack S.P.A. · Jul 2005