Cleared Traditional

K110378 - IMPRESSION COMPOUND

K110378 is an FDA 510(k) clearance for IMPRESSION COMPOUND, manufactured by Spofadental. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K110378 · Spofadental · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2011
Decision
83d
Days
Class 2
Risk

K110378 is an FDA 510(k) clearance for the IMPRESSION COMPOUND. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Spofadental (Orange, US). The FDA issued a Cleared decision on April 5, 2011 after a review of 83 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Spofadental devices

FDA 510(k) Submission Details - K110378

510(k) Number K110378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2011
Decision Date April 05, 2011
Days to Decision 83 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 127d · This submission: 83d
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 262
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K110378.
AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL
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FIT CHECKER ADVANCED
K110871 · GC America, Inc. · Jun 2011
TAKE 1 ADVANCED RIGID TRAY
K110092 · Kerr Corporation · Apr 2011
FIT TEST C&B
K110050 · Voco GmbH · Mar 2011
VONFLEX HEAVY, VINFLEX LIGHT
K103164 · Vericom Co., Ltd. · Nov 2010
TAKE 1 ADVANCED RIGID TRAY
K092176 · Kerr Corporation · Jan 2010