Cleared Traditional

K992879 - ECUSIT COMPOSITE REPAIR

K992879 is an FDA 510(k) clearance for ECUSIT COMPOSITE REPAIR, manufactured by Dmg Hamburg. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K992879 · Dmg Hamburg · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
75d
Days
Class 2
Risk

K992879 is an FDA 510(k) clearance for the ECUSIT COMPOSITE REPAIR. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Dmg Hamburg (Ayer, US). The FDA issued a Cleared decision on November 9, 1999 after a review of 75 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 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 Dmg Hamburg devices

FDA 510(k) Submission Details - K992879

510(k) Number K992879 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1999
Decision Date November 09, 1999
Days to Decision 75 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
52d faster than avg
Panel avg: 127d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 374
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K992879.
PULPDENT UNO-DUO
K993683 · Pulpdent Corp. · Dec 1999
SURE BOND
K993013 · Miradent Distributing Co., LLC · Nov 1999
ADHERE CONDITIONER, ADHERE PRIMER, ADHERE LC ADHESIVE, ADHERE DC ADHERE DC ACTIVATOR, ADHERE CYLANATE
K992838 · Biomat Sciences, Inc. · Nov 1999
GLUMA COMFORT BOND
K992985 · Heraeus Kulzer, Inc. · Oct 1999
GLUMA COMFORT BOND + DESENSITIZER
K992292 · Heraeus Kulzer, Inc. · Oct 1999
MODIFICATION OF PROMPT L-POP
K992048 · Espe Dental AG · Aug 1999