Cleared Traditional

K081705 - LANG DENTAL RESINCAP PATTERN AND COPING ACRYLIC RESIN

K081705 is an FDA 510(k) clearance for LANG DENTAL RESINCAP PATTERN AND COPING..., 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 92-day FDA review.

K081705 · Lang Dental Mfg. Co., Inc. · Dental device
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Sep 2008
Decision
92d
Days
Class 2
Risk

K081705 is an FDA 510(k) clearance for the LANG DENTAL RESINCAP PATTERN AND COPING 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 September 17, 2008 after a review of 92 days - within the typical 510(k) review window.

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 - K081705

510(k) Number K081705 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2008
Decision Date September 17, 2008
Days to Decision 92 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
35d faster than avg
Panel avg: 127d · This submission: 92d
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 K081705.
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