Cleared Traditional

K120784 - TUFF-TEMP 2.0

K120784 is the FDA 510(k) clearance for TUFF-TEMP 2.0 by Pulpdent Corporation. It is a Class 2 Dental device (product code EBG) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K120784 · Pulpdent Corporation · Dental device
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Optimized for regulatory review, auditing and printing
Jun 2012
Decision
85d
Days
Class 2
Risk

K120784 is an FDA 510(k) clearance for the TUFF-TEMP 2.0. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Pulpdent Corporation (Watertown, US). The FDA issued a Cleared decision on June 8, 2012 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3770 - 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 Pulpdent Corporation devices

Submission Details

510(k) Number K120784 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2012
Decision Date June 08, 2012
Days to Decision 85 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 127d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBG Crown And Bridge, Temporary, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3770
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 - EBG Crown And Bridge, Temporary, Resin

All 92
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K120784.
TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUT
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