Cleared Traditional

K990817 - IPS D.SIGN PORCELAIN

K990817 is the FDA 510(k) clearance for IPS D.SIGN PORCELAIN by Ivoclar North America, Inc.. It is a Class 2 Dental device (product code EIH) cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K990817 · Ivoclar North America, Inc. · Dental device
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Apr 1999
Decision
26d
Days
Class 2
Risk

K990817 is an FDA 510(k) clearance for the IPS D.SIGN PORCELAIN. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Ivoclar North America, Inc. (Amherst, US). The FDA issued a Cleared decision on April 6, 1999 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6660 - 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

Submission Details

510(k) Number K990817 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1999
Decision Date April 06, 1999
Days to Decision 26 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
101d faster than avg
Panel avg: 127d · This submission: 26d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EIH Powder, Porcelain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6660
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 - EIH Powder, Porcelain

All 275
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K990817.
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PROCERA ALLCERAM FUSING MATERIAL
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IPS EMPRESS 2
K982616 · Ivoclar North America, Inc. · Sep 1998
OPC LOWWEAR PORCELAIN
K982377 · Jeneric/Pentron, Inc. · Aug 1998