Cleared Traditional

K120784 - TUFF-TEMP 2.0

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

K120784 · Pulpdent Corporation · Dental device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K120784

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
Combination Product No
PCCP Authorized No
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.

EBG Device Classification - Class 2, Special Controls

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 150
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K120784.
KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+B-08, KINGSCROSS B
K122039 · Kettenbach GmbH & Co. KG · Dec 2012
BRIGHTGLASS BRIGHTGLASS M
K122025 · Ktk Medical Supplies GmbH · Oct 2012
PMMA CAD/CAM DISC
K112967 · Polident D.O.O., Dental Products Industry · Aug 2012
STRUCTUR 3
K120779 · Voco GmbH · Jun 2012
FIBER DISK AND BLOCK
K112186 · Bioloren S.R.L. · Nov 2011
EVADYNE TEMPORARY CROWN AND BRIDGE RESIN
K111666 · Neodental Chemical Products Co., Ltd. · Sep 2011