Cleared Traditional

K152392 - VINTAGE LD

K152392 is an FDA 510(k) clearance for VINTAGE LD, manufactured by Shofu Dental Corporation. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K152392

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.

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 399
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