Cleared Special

K061264 - TEMPFX ESTHETIC PROVISIONAL SYSTEM

K061264 is an FDA 510(k) clearance for TEMPFX ESTHETIC PROVISIONAL SYSTEM, manufactured by Dentsply International, Inc.. The device is a Class 2 Dental device with product code EBG cleared through the Special 510(k) pathway after a 18-day FDA review.

K061264 · Dentsply International, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
18d
Days
Class 2
Risk

K061264 is an FDA 510(k) clearance for the TEMPFX ESTHETIC PROVISIONAL SYSTEM. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Dentsply International, Inc. (York, US). The FDA issued a Cleared decision on May 23, 2006 after a review of 18 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K061264

510(k) Number K061264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2006
Decision Date May 23, 2006
Days to Decision 18 days
Submission Type Special
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
110d faster than avg
Panel avg: 128d · This submission: 18d
Pathway characteristics
Modification to existing cleared device.

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 186
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K061264.
KAVO EVEREST C-TEMP
K063624 · Kavo America · Feb 2007
ARTEGRAL IMCROWN
K061809 · Merz Dental GmbH · Sep 2006
MD-TEMP
K061530 · Meta Biomed Co., Ltd. · Jul 2006
TEMPORARY CROWN & BRIDGE RESIN
K060881 · Cosmedent, Inc. · May 2006
PROVISIONAL INLAY/ONLAY KIT
K052800 · Dmg USA, Inc. · Mar 2006
TEMPORARY CROWN AND BRIDGE MATERIAL
K060293 · Dentsply International, Inc. · Feb 2006
K061264 · TEMPFX ESTHETIC PROVISIONAL SYSTEM
Download PDF FDA Summary Dentsply Internationa…