Cleared Traditional

K020898 - D.SIGN 15 (DW286 B)

K020898 is the FDA 510(k) clearance for D.SIGN 15 (DW286 B) by Ivoclar Vivadent, Inc.. It is a Class 2 Dental device (product code EJH) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K020898 · Ivoclar Vivadent, Inc. · Dental device
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Mar 2002
Decision
64d
Days
Class 2
Risk

K020898 is an FDA 510(k) clearance for the D.SIGN 15 (DW286 B). Classified as Alloy, Metal, Base (product code EJH), Class II - Special Controls.

Submitted by Ivoclar Vivadent, Inc. (Amherst, US). The FDA issued a Cleared decision on March 29, 2002 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3710 - 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 K020898 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2002
Decision Date March 29, 2002
Days to Decision 64 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
63d faster than avg
Panel avg: 127d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EJH Alloy, Metal, Base
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3710
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 - EJH Alloy, Metal, Base

All 31
Devices cleared under the same product code (EJH) and FDA review panel - the closest regulatory comparables to K020898.
4 ALL (DW286A)
K020253 · Ivoclar Vivadent, Inc. · Apr 2002
PISCES PLUS (DW286 C)
K020183 · Ivoclar Vivadent, Inc. · Mar 2002
D.SIGN 30
K010381 · Ivoclar North America, Inc. · Mar 2001
AUROFILM NP
K003387 · Metalor Dental USA Corp. · Jan 2001
JEWEL CAST III
K003037 · Jeneric/Pentron, Inc. · Dec 2000
GOLD CORE II
K003039 · Jeneric/Pentron, Inc. · Dec 2000