Cleared Traditional

K984451 - D-SIGN I (R&D PROJECT DW263 #24)

K984451 is an FDA 510(k) clearance for D-SIGN I (R&D PROJECT DW263 #24), manufactured by Ivoclar North America, Inc.. The device is a Class 2 Dental device with product code EJS cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K984451 · Ivoclar North America, Inc. · Dental device
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Jan 1999
Decision
35d
Days
Class 2
Risk

K984451 is an FDA 510(k) clearance for the D-SIGN I (R&D PROJECT DW263 #24). Classified as Alloy, Other Noble Metal (product code EJS), Class II - Special Controls.

Submitted by Ivoclar North America, Inc. (Amherst, US). The FDA issued a Cleared decision on January 19, 1999 after a review of 35 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 North America, Inc. devices

FDA 510(k) Submission Details - K984451

510(k) Number K984451 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1998
Decision Date January 19, 1999
Days to Decision 35 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
92d faster than avg
Panel avg: 127d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJS Device Classification - Class 2, Special Controls

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 171
Devices cleared under the same product code (EJS) and FDA review panel - the closest regulatory comparables to K984451.
ALLROUND-E (CODE NAME RD 1710)
K984587 · J.F. Jelenko & Co., Inc. · Mar 1999
D-SIGN III (R&D PROJECT DW264#7)
K990077 · Ivoclar North America, Inc. · Feb 1999
D-SIGN IV (R&D PROJECT DW265#37)
K990078 · Ivoclar North America, Inc. · Feb 1999
BEGOPAL 300
K983081 · Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO · Oct 1998
BEGOPAL
K983078 · Bego U.S.A. · Oct 1998
JELFINE-52 (CODE NAME RD-0901)
K981257 · J.F. Jelenko & Co., Inc. · Aug 1998