Cleared Traditional

K051933 - EXPASYL POWER APPLICATOR

K051933 is the FDA 510(k) clearance for EXPASYL POWER APPLICATOR by Sybron Dental Specialties, Inc.. It is a Class 2 Dental device (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

Submission Details

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.

Device Classification

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 124
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K051933.
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MODIFICATION TO:REGISTRADO X-TRA
K051535 · Voco GmbH · Jun 2005
KERR VPS IMPRESSION MATERIAL
K050604 · Sybron Dental Specialties, Inc. · Apr 2005
FUSION PUTTY TYPE
K043493 · GC America, Inc. · Mar 2005