Cleared Traditional

K991913 - PENTAMIX 2

K991913 is the FDA 510(k) clearance for PENTAMIX 2 by Espe Dental AG. It is a Class 1 Dental device (product code EFD) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K991913 · Espe Dental AG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
49d
Days
Class 1
Risk

K991913 is an FDA 510(k) clearance for the PENTAMIX 2. Classified as Amalgamator, Dental, Ac-powered (product code EFD), Class I - General Controls.

Submitted by Espe Dental AG (Bavaria D-82228 Seefeld, DE). The FDA issued a Cleared decision on July 26, 1999 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3100 - 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 K991913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1999
Decision Date July 26, 1999
Days to Decision 49 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
78d faster than avg
Panel avg: 127d · This submission: 49d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFD Amalgamator, Dental, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3100
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EFD Amalgamator, Dental, Ac-powered

All 7
Devices cleared under the same product code (EFD) and FDA review panel - the closest regulatory comparables to K991913.
SILIMAT PLUS
K923974 · Ivoclar North America, Inc. · Oct 1992
AUTOMIX DENTAL AMALGAMATOR
K915847 · Kerr Corporation (Danbury) · Mar 1992
DUOMAT 3 AMALGAMATOR
K914340 · Degussa AG · Nov 1991
MIXOMAT AMALGAMATOR
K914341 · Degussa AG · Nov 1991
DENTOMAT 3 AMALGAMATORS
K914339 · Degussa AG · Nov 1991
SILAMAT (AMALGAMATOR)
K901909 · Ivoclar North America, Inc. · Jun 1990