Cleared Traditional

K013809 - D.SIGN 59

K013809 is the FDA 510(k) clearance for D.SIGN 59 by Ivoclar Vivadent, Inc.. It is a Class 2 Dental device (product code EJS) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K013809 · Ivoclar Vivadent, Inc. · Dental device
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Feb 2002
Decision
84d
Days
Class 2
Risk

K013809 is an FDA 510(k) clearance for the D.SIGN 59. Classified as Alloy, Other Noble Metal (product code EJS), Class II - Special Controls.

Submitted by Ivoclar Vivadent, Inc. (Amherst, US). The FDA issued a Cleared decision on February 7, 2002 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3060 - 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 K013809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2001
Decision Date February 07, 2002
Days to Decision 84 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
43d faster than avg
Panel avg: 127d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EJS Alloy, Other Noble Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3060
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 - EJS Alloy, Other Noble Metal

All 110
Devices cleared under the same product code (EJS) and FDA review panel - the closest regulatory comparables to K013809.
SIMIDUR KF PLUS
K020194 · Wieland Dental + Technik GmbH & Co. KG · Mar 2002
SIMIDUR S1S
K020195 · Wieland Dental + Technik GmbH & Co. KG · Mar 2002
D.SIGN 84
K014042 · Ivoclar Vivadent, Inc. · Feb 2002
D.SIGN 53, MODEL NA1012204
K014082 · Ivoclar Vivadent, Inc. · Jan 2002
JEL-20
K012303 · J.F. Jelenko & Co., Inc. · Aug 2001
DW 273 #1
K003632 · Ivoclar North America, Inc. · Dec 2000