Cleared Traditional

K152392 - VINTAGE LD

K152392 is the FDA 510(k) clearance for VINTAGE LD by Shofu Dental Corporation. It is a Class 2 Dental device (product code EIH) cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K152392 · Shofu Dental Corporation · Dental device
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Jan 2016
Decision
137d
Days
Class 2
Risk

K152392 is an FDA 510(k) clearance for the VINTAGE LD. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Shofu Dental Corporation (San Marcos, US). The FDA issued a Cleared decision on January 8, 2016 after a review of 137 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.

View all Shofu Dental Corporation devices

Submission Details

510(k) Number K152392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2015
Decision Date January 08, 2016
Days to Decision 137 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 127d · This submission: 137d
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 248
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K152392.
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K150872 · Prismatik Dentalcraft, Inc. · Jul 2015