Cleared Traditional

K151945 - Triumph Resin Dam

K151945 is an FDA 510(k) clearance for Triumph Resin Dam, manufactured by Denali Corporation. The device is a Class 1 Dental device with product code EIE cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K151945 · Denali Corporation · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2016
Decision
219d
Days
Class 1
Risk

K151945 is an FDA 510(k) clearance for the Triumph Resin Dam. Classified as Dam, Rubber (product code EIE), Class I - General Controls.

Submitted by Denali Corporation (Hanover, US). The FDA issued a Cleared decision on February 18, 2016 after a review of 219 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6300 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K151945

510(k) Number K151945 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2015
Decision Date February 18, 2016
Days to Decision 219 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
91d slower than avg
Panel avg: 128d · This submission: 219d
Pathway characteristics
Predicate-based equivalence.

EIE Device Classification - Class 1, General Controls

Product Code EIE Dam, Rubber
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6300
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 - EIE Dam, Rubber

All 17
Devices cleared under the same product code (EIE) and FDA review panel - the closest regulatory comparables to K151945.
armor LC
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K043301 · GC America, Inc. · Jan 2005
BRITESMILE MASKING CREAM
K040797 · Britesmile, Inc. · Apr 2004
PULPDENT PUTTY DAM
K022522 · Pulpdent Corporation · Sep 2002
LIGHT CURE DENTAL DAM
K021524 · Prime Dental Manufacturing, Inc. · Jul 2002