Cleared Traditional

K032165 - VINTAGE AL

K032165 is an FDA 510(k) clearance for VINTAGE AL, manufactured by Shofu Dental Corp.. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K032165 · Shofu Dental Corp. · Dental device
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Sep 2003
Decision
63d
Days
Class 2
Risk

K032165 is an FDA 510(k) clearance for the VINTAGE AL. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Shofu Dental Corp. (San Marcos, US). The FDA issued a Cleared decision on September 16, 2003 after a review of 63 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shofu Dental Corp. devices

FDA 510(k) Submission Details - K032165

510(k) Number K032165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2003
Decision Date September 16, 2003
Days to Decision 63 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
64d faster than avg
Panel avg: 127d · This submission: 63d
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 324
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K032165.
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