Cleared Traditional

K915543 - NEW OPAQUE PORCELAIN

K915543 is an FDA 510(k) clearance for NEW OPAQUE PORCELAIN, manufactured by Dentsply Intl.. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K915543 · Dentsply Intl. · Dental device
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Mar 1992
Decision
100d
Days
Class 2
Risk

K915543 is an FDA 510(k) clearance for the NEW OPAQUE PORCELAIN. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on March 19, 1992 after a review of 100 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 Dentsply Intl. devices

FDA 510(k) Submission Details - K915543

510(k) Number K915543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1991
Decision Date March 19, 1992
Days to Decision 100 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
27d faster than avg
Panel avg: 127d · This submission: 100d
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 431
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K915543.
VITA IN-CERAM
K913644 · Vident · Jun 1992
DUCERATIN/DUCERAM LFC DENTAL PORCELAIN
K921479 · Degussa AG · Jun 1992
VITA OMEGA PORCELAIN
K921474 · Vident · Jun 1992
IPS EMPRESS
K913372 · Ivoclar North America, Inc. · Oct 1991
PLATINUM FOIL, VARIOUS SIZES
K905321 · Ivoclar North America, Inc. · Feb 1991
WILL-CERAM BRUSHES, SUPER BRUSH KIT
K905328 · Ivoclar North America, Inc. · Jan 1991