Cleared Traditional

K083195 - MACH 4 JET TOOTH SHADE PROVISONAL CROWN AND BRIDGE ACRYLIC RESIN

K083195 is an FDA 510(k) clearance for MACH 4 JET TOOTH SHADE PROVISONAL CROWN..., manufactured by Lang Dental Mfg. Co., Inc.. The device is a Class 2 Dental device with product code EBG cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K083195 · Lang Dental Mfg. Co., Inc. · Dental device
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Jun 2009
Decision
219d
Days
Class 2
Risk

K083195 is an FDA 510(k) clearance for the MACH 4 JET TOOTH SHADE PROVISONAL CROWN AND BRIDGE ACRYLIC RESIN. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Lang Dental Mfg. Co., Inc. (Wheeling, US). The FDA issued a Cleared decision on June 5, 2009 after a review of 219 days - an extended review 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: 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.

View all Lang Dental Mfg. Co., Inc. devices

FDA 510(k) Submission Details - K083195

510(k) Number K083195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2008
Decision Date June 05, 2009
Days to Decision 219 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d slower than avg
Panel avg: 127d · This submission: 219d
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 123
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K083195.
LUXATEMP ULTRA /STAR
K101710 · Dmg USA, Inc. · Sep 2010
TELIO CAD
K093708 · Ivoclar Vivadent, Inc. · Mar 2010
TEMPORARY C&B COMPOSITE
K091894 · Voco GmbH · Jul 2009
PULPDENT TEMPORARY CROWN AND BRIDGE MATERIAL
K081810 · Pulpdent Corporation · Sep 2008
UNIFAST III
K073106 · GC America, Inc. · Apr 2008
ZENO PMMA DISC
K080182 · Wieland Dental + Technik GmbH & Co. KG · Apr 2008