Cleared Traditional

K080311 - MODIFIED TEMPRX ESTHETIC PROVISIONAL SYSTEM

K080311 is an FDA 510(k) clearance for MODIFIED TEMPRX ESTHETIC PROVISIONAL SYSTEM, manufactured by Dentsply Interntional. The device is a Class 2 Dental device with product code EBG cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K080311 · Dentsply Interntional · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
72d
Days
Class 2
Risk

K080311 is an FDA 510(k) clearance for the MODIFIED TEMPRX ESTHETIC PROVISIONAL SYSTEM. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Dentsply Interntional (York, US). The FDA issued a Cleared decision on April 18, 2008 after a review of 72 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.

FDA 510(k) Submission Details - K080311

510(k) Number K080311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2008
Decision Date April 18, 2008
Days to Decision 72 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
56d faster than avg
Panel avg: 128d · This submission: 72d
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 177
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K080311.
LANG DENTAL RESINCAP PATTERN AND COPING ACRYLIC RESIN
K081705 · Lang Dental Mfg. Co., Inc. · Sep 2008
PULPDENT TEMPORARY CROWN AND BRIDGE MATERIAL
K081810 · Pulpdent Corporation · Sep 2008
ARTBLOC TEMP, DIMENSION: 15.5 X19.39 MM V-CLASSIC SHADES AND BLEACH SHADES
K080556 · Merz Dental GmbH · May 2008
UNIFAST III
K073106 · GC America, Inc. · Apr 2008
ZENO PMMA DISC
K080182 · Wieland Dental + Technik GmbH & Co. KG · Apr 2008
PRO-V
K073263 · Bisco, Inc. · Feb 2008
K080311 · MODIFIED TEMPRX ESTHETIC PROVISIONAL SYSTEM
Download PDF FDA Summary Dentsply Interntional