Cleared Traditional

K042820 - SYSTEMP.C&B PLUS

K042820 is the FDA 510(k) clearance for SYSTEMP.C&B PLUS by Ivoclar Vivadent, Inc.. It is a Class 2 Dental device (product code EBG) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K042820 · Ivoclar Vivadent, Inc. · Dental device
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Dec 2004
Decision
63d
Days
Class 2
Risk

K042820 is an FDA 510(k) clearance for the SYSTEMP.C&B PLUS. 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 December 14, 2004 after a review of 63 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ivoclar Vivadent, Inc. devices

Submission Details

510(k) Number K042820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2004
Decision Date December 14, 2004
Days to Decision 63 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
64d faster than avg
Panel avg: 127d · This submission: 63d
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 K042820.
PRO-V
K073263 · Bisco, Inc. · Feb 2008
TEMPFX ESTHETIC PROVISIONAL SYSTEM
K061264 · Dentsply International, Inc. · May 2006
TEMPORARY CROWN AND BRIDGE MATERIAL
K060293 · Dentsply International, Inc. · Feb 2006
PROVISO
K041886 · Scientific Pharmaceuticals, Inc. · Aug 2004
SR ADORO
K040951 · Ivoclar Vivadent, Inc. · May 2004
STRUCTUR 2 SC
K040769 · Voco GmbH · Apr 2004