Cleared Traditional

K990235 - D-SIGN VI (R&D PROJECT DW266#9)

K990235 is an FDA 510(k) clearance for D-SIGN VI (R&D PROJECT DW266#9), manufactured by Ivoclar North America, Inc.. The device is a Class 2 Dental device with product code EJH cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K990235 · Ivoclar North America, Inc. · Dental device
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Mar 1999
Decision
35d
Days
Class 2
Risk

K990235 is an FDA 510(k) clearance for the D-SIGN VI (R&D PROJECT DW266#9). Classified as Alloy, Metal, Base (product code EJH), Class II - Special Controls.

Submitted by Ivoclar North America, Inc. (Amherst, US). The FDA issued a Cleared decision on March 1, 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 872.3710 - 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 North America, Inc. devices

FDA 510(k) Submission Details - K990235

510(k) Number K990235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1999
Decision Date March 01, 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.

EJH Device Classification - Class 2, Special Controls

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 99
Devices cleared under the same product code (EJH) and FDA review panel - the closest regulatory comparables to K990235.
P10 SPECIAL
K993344 · North American Alloys, Inc. · Nov 1999
CERADIUM NON-PRECIOUS CERAMIC ALLOY
K992705 · Matech, Inc. · Sep 1999
D-SIGN V (R&D PROJECT DW267#17)
K990182 · Ivoclar North America, Inc. · Mar 1999
JELBOND NP
K984164 · Jelenko Co. · Dec 1998
VERABOND 2
K982094 · Aalba Dent, Inc. · Jul 1998
NPG + 2
K972971 · Aalba Dent, Inc. · Jan 1998