Cleared Traditional

K994192 - IMPREGUM PENTA M MONOSOFT

K994192 is the FDA 510(k) clearance for IMPREGUM PENTA M MONOSOFT by Espe Dental AG. It is a Class 2 Dental device (product code ELW) cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K994192 · Espe Dental AG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2000
Decision
46d
Days
Class 2
Risk

K994192 is an FDA 510(k) clearance for the IMPREGUM PENTA M MONOSOFT. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Espe Dental AG (Bavaria D-82228 Seefeld, DE). The FDA issued a Cleared decision on January 28, 2000 after a review of 46 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 Espe Dental AG devices

Submission Details

510(k) Number K994192 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1999
Decision Date January 28, 2000
Days to Decision 46 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
81d faster than avg
Panel avg: 127d · This submission: 46d
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 167
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K994192.
DIMENSION GARANT L, DIMENSION GARANT L QUICK
K000588 · Espe Dental AG · Mar 2000
DIMENSION PENTA H, DIMENSION PENTA H QUICK
K000591 · Espe Dental AG · Mar 2000
CEREC 3
K994172 · Sirona Dental Systems GmbH · Feb 2000
IMPREGUM PENTA DUOSOFT
K994193 · Espe Dental AG · Jan 2000
AROMA FINE (NORMAL AND FAST SET)
K994077 · GC America, Inc. · Jan 2000
IMPREGUM GARANT L DUOSOFT
K994190 · Espe Dental AG · Jan 2000