Cleared Abbreviated

K000878 - HONIGUM

K000878 is an FDA 510(k) clearance for HONIGUM, manufactured by Dmg USA, Inc.. The device is a Class 2 Dental device with product code ELW cleared through the Abbreviated 510(k) pathway after a 22-day FDA review.

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

FDA 510(k) Submission Details - K000878

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 127d · This submission: 22d
Pathway characteristics
Standards-based clearance path.

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 229
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K000878.
CORRECT PLUS
K001218 · Jeneric/Pentron, Inc. · Jul 2000
KROM-ALGINATE AND ALGINATE PLUS
K000686 · Cavex Holland BV · May 2000
ACTIVATOR PASTE
K994027 · Harry J. Bosworth Co. · Apr 2000
DIMENSION PENTA L
K000595 · Espe Dental AG · Apr 2000
FLEXTIME
K000629 · Heraeus Kulzer, Inc. · Apr 2000
DIMENSION GARANT L, DIMENSION GARANT L QUICK
K000588 · Espe Dental AG · Mar 2000