Cleared Special

K162537 - CAD/CAMouflage Milling Block

K162537 is an FDA 510(k) clearance for CAD/CAMouflage Milling Block, manufactured by Prismatik Dentalcraft, Inc.. The device is a Class 2 Dental device with 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) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K162537

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
63d faster than avg
Panel avg: 128d · This submission: 65d
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.

Regulatory Peers - EBF Material, Tooth Shade, Resin

All 901
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K162537.
Tooth Shade Resin Material
K162323 · Liaoning Upcera Co., Ltd. · Jan 2017
CERAMAGE UP
K162261 · Shofu Dental Corporation · Jan 2017
Filtek One Bulk Fill Restorative
K163207 · 3M Company · Nov 2016
Charisma
K160049 · Heraeus Kulzer, LLC, Mitsui Chemicals Group · Nov 2016
P1145 Dental Restorative
K162257 · Kerr Corporation · Nov 2016
Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq Flow
K151399 · Schutz-Dental GmbH · Oct 2016
K162537 · CAD/CAMouflage Milling Block
Download PDF FDA Summary Prismatik Dentalcraft…