Cleared Special

K032851 - ULTRACROWN 75 ALLOY

K032851 is an FDA 510(k) clearance for ULTRACROWN 75 ALLOY, manufactured by Dentsply International. The device is a Class 2 Dental device with product code EJT cleared through the Special 510(k) pathway after a 14-day FDA review.

K032851 · Dentsply International · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2003
Decision
14d
Days
Class 2
Risk

K032851 is an FDA 510(k) clearance for the ULTRACROWN 75 ALLOY. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by Dentsply International (York, US). The FDA issued a Cleared decision on September 26, 2003 after a review of 14 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Dentsply International devices

FDA 510(k) Submission Details - K032851

510(k) Number K032851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2003
Decision Date September 26, 2003
Days to Decision 14 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 127d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

EJT Device Classification - Class 2, Special Controls

Product Code EJT Alloy, Gold-based 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 - EJT Alloy, Gold-based Noble Metal

All 489
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K032851.
CERA R PLUS ALLOY
K032319 · Dentsply International · Sep 2003
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DW 296 #15 SOLDER
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ALEXANDER
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PORTA PRESSOVER
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K030435 · Ivoclar Vivadent, Inc. · Apr 2003