Cleared Traditional

K113575 - HILLA DIGITAL TRANSFERS

K113575 is an FDA 510(k) clearance for HILLA DIGITAL TRANSFERS, manufactured by Hilla Technologies, Inc.. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K113575 · Hilla Technologies, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
96d
Days
Class 2
Risk

K113575 is an FDA 510(k) clearance for the HILLA DIGITAL TRANSFERS. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Hilla Technologies, Inc. (Bradenton, US). The FDA issued a Cleared decision on March 7, 2012 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6660 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K113575

510(k) Number K113575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2011
Decision Date March 07, 2012
Days to Decision 96 days
Submission Type Traditional
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
32d faster than avg
Panel avg: 128d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 482
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K113575.
IPS E.MAX PRESS MULTI
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HEISENBERG EFFECT SHADES
K120011 · 3M Espe AG · Jan 2012
JENSEN ZIRCONIA
K112806 · Jensen Industries, Inc. · Dec 2011
CERCON HT
K112152 · Dentsply International, Inc. · Nov 2011
K113575 · HILLA DIGITAL TRANSFERS
Download PDF FDA Summary Hilla Technologies, I…