Cleared Abbreviated

HONIGUM (K000878) - FDA 510(k) Clearance

Class II Dental device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K000878 · Dmg USA, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
22d
Days
Class 2
Risk

K000878 is an FDA 510(k) clearance for the HONIGUM. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Dmg USA, Inc. (Ayer, US). The FDA issued a Cleared decision on April 11, 2000 after a review of 22 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Dmg USA, Inc. devices

Submission Details

510(k) Number K000878 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2000
Decision Date April 11, 2000
Days to Decision 22 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 127d · This submission: 22d
Pathway characteristics
Standards-based clearance path.

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 94
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K000878.
PERMLASTIC 3
K003650 · Sybron Dental Specialties, Inc. · Feb 2001
FLEXTIME MAGNUM 360
K003930 · Heraeus Kulzer, Inc. · Feb 2001
TAKE 1 BITE
K001876 · Sybron Dental Specialties, Inc. · Jul 2000
FLEXTIME
K000629 · Heraeus Kulzer, Inc. · Apr 2000
AROMA FINE (NORMAL AND FAST SET)
K994077 · GC America, Inc. · Jan 2000
XANTOPREN COMFORT
K991425 · Heraeus Kulzer, Inc. · Jun 1999