Cleared Abbreviated

K041960 - COMPOSITE/COMPOMER REPAIR KIT

K041960 is an FDA 510(k) clearance for COMPOSITE/COMPOMER REPAIR KIT, manufactured by Dmg USA, Inc.. The device is a Class 2 Dental device with product code KLE cleared through the Abbreviated 510(k) pathway after a 40-day FDA review.

K041960 · Dmg USA, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2004
Decision
40d
Days
Class 2
Risk

K041960 is an FDA 510(k) clearance for the COMPOSITE/COMPOMER REPAIR KIT. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Dmg USA, Inc. (Dover, US). The FDA issued a Cleared decision on August 30, 2004 after a review of 40 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3200 - 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 - K041960

510(k) Number K041960 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2004
Decision Date August 30, 2004
Days to Decision 40 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
87d faster than avg
Panel avg: 127d · This submission: 40d
Pathway characteristics
Standards-based clearance path.

KLE Device Classification - Class 2, Special Controls

Product Code KLE Agent, Tooth Bonding, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3200
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 - KLE Agent, Tooth Bonding, Resin

All 382
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K041960.
ORAJEL ADVANCED TOOTH DESENSITIZER
K041680 · Del Pharmaceuticals, Inc. · Nov 2004
FUTURABOND NR
K042670 · Voco GmbH · Nov 2004
M.L. PRIMER
K040079 · Shofu Dental Corp. · Sep 2004
G-BOND
K041471 · GC America, Inc. · Jun 2004
XENO NM LIGHT CURED DENTAL ADHESIVE
K041343 · Dentsply International · Jun 2004
MODIFICATION TO ADPER PROMPT
K040857 · 3M Espe AG Dental Products · May 2004