Cleared Traditional

K984427 - EXCELSIOR PORCELAIN SYSTEM

K984427 is an FDA 510(k) clearance for EXCELSIOR PORCELAIN SYSTEM, manufactured by Ney Dental, Inc.. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K984427 · Ney Dental, Inc. · Dental device
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Mar 1999
Decision
94d
Days
Class 2
Risk

K984427 is an FDA 510(k) clearance for the EXCELSIOR PORCELAIN SYSTEM. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Ney Dental, Inc. (Deerfield Beach, US). The FDA issued a Cleared decision on March 15, 1999 after a review of 94 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Ney Dental, Inc. devices

FDA 510(k) Submission Details - K984427

510(k) Number K984427 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1998
Decision Date March 15, 1999
Days to Decision 94 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
33d faster than avg
Panel avg: 127d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EIH Device Classification - Class 2, Special Controls

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 352
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K984427.
IPS D.SIGN PORCELAIN
K990817 · Ivoclar North America, Inc. · Apr 1999
VISION PORCELAIN
K990790 · Servo Dental USA, Inc. · Apr 1999
SYMBIOCERAM
K990629 · Ney Dental, Inc. · Mar 1999
SUPER PORCELAIN STAIN- PURE WHITE
K983470 · Noritake Co., Inc. · Dec 1998
PROCERA ALLCERAM FUSING MATERIAL
K983453 · Nobel Biocare Uas, Inc. · Nov 1998
SUPER PORCELAIN ADDMATE
K983247 · Noritake Co., Inc. · Nov 1998