Cleared Traditional

K954192 - IMPREGUM PENTA

K954192 is an FDA 510(k) clearance for IMPREGUM PENTA, manufactured by Espe GmbH & Co. Kg.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K954192 · Espe GmbH & Co. Kg. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1995
Decision
86d
Days
Class 2
Risk

K954192 is an FDA 510(k) clearance for the IMPREGUM PENTA. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Espe GmbH & Co. Kg. (Seefeld, DE). The FDA issued a Cleared decision on December 1, 1995 after a review of 86 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 GmbH & Co. Kg. devices

FDA 510(k) Submission Details - K954192

510(k) Number K954192 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1995
Decision Date December 01, 1995
Days to Decision 86 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
41d faster than avg
Panel avg: 127d · This submission: 86d
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 254
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K954192.
BOSWORTH IMPRESSION MATERIAL I
K960063 · Harry J. Bosworth Co. · Feb 1996
SCAN WHITE 12 ML
K955406 · Vident · Dec 1995
DEGUPRINT
K955465 · Degussa Corp. · Dec 1995
MICROGLISS
K954180 · Espe GmbH & Co. Kg. · Nov 1995
RETRAC
K952728 · Centrix, Inc. · Sep 1995
AMERICAN DENTAL PRODUCTS ALGINATE FLAVORING
K954223 · American Dental Products, Inc. · Sep 1995