Cleared Special

K030859 - NOVA CERAMIC SPRAY GLAZE AND TRU-PAQUE, OPAQUE PORCELAIN

K030859 is an FDA 510(k) clearance for NOVA CERAMIC SPRAY GLAZE AND TRU-PAQUE, manufactured by Enamelite, LLC. The device is a Class 2 Dental device with product code EIH cleared through the Special 510(k) pathway after a 9-day FDA review.

K030859 · Enamelite, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2003
Decision
9d
Days
Class 2
Risk

K030859 is an FDA 510(k) clearance for the NOVA CERAMIC SPRAY GLAZE AND TRU-PAQUE, OPAQUE PORCELAIN. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Enamelite, LLC (Clarksville, US). The FDA issued a Cleared decision on March 27, 2003 after a review of 9 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. 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 Enamelite, LLC devices

FDA 510(k) Submission Details - K030859

510(k) Number K030859 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2003
Decision Date March 27, 2003
Days to Decision 9 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 127d · This submission: 9d
Pathway characteristics
Modification to existing cleared device.

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 308
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K030859.
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