Cleared Special

K052097 - CERAM X UNIVERSAL MANO-CERAMIC RESTORATIVE

K052097 is an FDA 510(k) clearance for CERAM X UNIVERSAL MANO-CERAMIC RESTORATIVE, manufactured by Dentsply International. The device is a Class 2 Dental device with product code EBF cleared through the Special 510(k) pathway after a 9-day FDA review.

K052097 · Dentsply International · Dental device
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Optimized for regulatory review, auditing and printing
Aug 2005
Decision
9d
Days
Class 2
Risk

K052097 is an FDA 510(k) clearance for the CERAM X UNIVERSAL MANO-CERAMIC RESTORATIVE. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Dentsply International (York, US). The FDA issued a Cleared decision on August 12, 2005 after a review of 9 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 - K052097

510(k) Number K052097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2005
Decision Date August 12, 2005
Days to Decision 9 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
118d faster than avg
Panel avg: 127d · This submission: 9d
Pathway characteristics
Modification to existing cleared device.

EBF Device Classification - Class 2, Special Controls

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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.