Cleared Traditional

K013869 - SR IVOCRON

K013869 is the FDA 510(k) clearance for SR IVOCRON by Ivoclar Vivadent, Inc.. It is a Class 2 Dental device (product code EBG) cleared through the Traditional 510(k) pathway after a 280-day FDA review.

K013869 · Ivoclar Vivadent, Inc. · Dental device
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Aug 2002
Decision
280d
Days
Class 2
Risk

K013869 is an FDA 510(k) clearance for the SR IVOCRON. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Ivoclar Vivadent, Inc. (Amherst, US). The FDA issued a Cleared decision on August 28, 2002 after a review of 280 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 Ivoclar Vivadent, Inc. devices

Submission Details

510(k) Number K013869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2001
Decision Date August 28, 2002
Days to Decision 280 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
153d slower than avg
Panel avg: 127d · This submission: 280d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 91
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K013869.
SR ADORO
K040951 · Ivoclar Vivadent, Inc. · May 2004
STRUCTUR 2 SC
K040769 · Voco GmbH · Apr 2004
FILL-IN
K031476 · Sybron Dental Specialties, Inc. · Jul 2003
TEMPORARY CROWN AND BRIDGE MATERIAL
K020157 · J. Morita USA, Inc. · Mar 2002
TEMPFIL
K013895 · Sybron Dental Specialties, Inc. · Feb 2002
LC TEMPORARY FILLING
K012360 · Parkell, Inc. · Sep 2001