Cleared Special

K162537 - CAD/CAMouflage Milling Block

K162537 is the FDA 510(k) clearance for CAD/CAMouflage Milling Block by Prismatik Dentalcraft, Inc.. It is a Class 2 Dental device (product code EBF) cleared through the Special 510(k) pathway after a 65-day FDA review.

K162537 · Prismatik Dentalcraft, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2016
Decision
65d
Days
Class 2
Risk

K162537 is an FDA 510(k) clearance for the CAD/CAMouflage Milling Block. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Prismatik Dentalcraft, Inc. (Irvine, US). The FDA issued a Cleared decision on November 16, 2016 after a review of 65 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 Prismatik Dentalcraft, Inc. devices

Submission Details

510(k) Number K162537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2016
Decision Date November 16, 2016
Days to Decision 65 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
62d faster than avg
Panel avg: 127d · This submission: 65d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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.

Regulatory Peers - EBF Material, Tooth Shade, Resin

All 468
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K162537.
REVEAL Bulk
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K162107 · Dentsply Sirona · Sep 2016
Clip Flow
K153493 · Voco GmbH · Jul 2016
CAD/CAMouflage Milling Bock
K160425 · Prismatik Dentalcraft, Inc. · Jul 2016