Cleared Traditional

K101814 - DIRECT CROWN NATURAL 1

K101814 is an FDA 510(k) clearance for DIRECT CROWN NATURAL 1, manufactured by Candulor USA, Inc.. The device is a Class 2 Dental device with product code EBG cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K101814 · Candulor USA, Inc. · Dental device
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Sep 2010
Decision
90d
Days
Class 2
Risk

K101814 is an FDA 510(k) clearance for the DIRECT CROWN NATURAL 1. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Candulor USA, Inc. (Los Angeles, US). The FDA issued a Cleared decision on September 27, 2010 after a review of 90 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 Candulor USA, Inc. devices

FDA 510(k) Submission Details - K101814

510(k) Number K101814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2010
Decision Date September 27, 2010
Days to Decision 90 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
37d faster than avg
Panel avg: 127d · This submission: 90d
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 122
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K101814.
PRO-V COAT
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K103379 · Ivoclar Vivadent, Inc. · Feb 2011
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