Cleared Traditional

Initial LiSi Block (K153130) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K153130 · GC America, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
319d
Days
Class 2
Risk

K153130 is an FDA 510(k) clearance for the Initial LiSi Block. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on September 13, 2016 after a review of 319 days - an unusually long review period, suggesting complex equivalence evaluation.

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

View all GC America, Inc. devices

Submission Details

510(k) Number K153130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2015
Decision Date September 13, 2016
Days to Decision 319 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
192d slower than avg
Panel avg: 127d · This submission: 319d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 188
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