Cleared Traditional

K181496 - VINTAGE PRO

K181496 is the FDA 510(k) clearance for VINTAGE PRO by Shofu Dental Corporation. It is a Class 2 Dental device (product code EIH) cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K181496 · Shofu Dental Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2018
Decision
194d
Days
Class 2
Risk

K181496 is an FDA 510(k) clearance for the VINTAGE PRO. 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 December 18, 2018 after a review of 194 days - an extended review 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: 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 K181496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2018
Decision Date December 18, 2018
Days to Decision 194 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
67d slower than avg
Panel avg: 127d · This submission: 194d
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 260
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K181496.
DD cube ONE ML
K183569 · Dental Direkt GmbH · Feb 2019
ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer
K182833 · The Argen Corporation · Feb 2019
GenesisZr™ 4Y Zirconia
K182642 · United Dental Resources Corporation · Jan 2019
Erran Dental Zirconia
K182068 · Hangzhou Erran Technology Co., Ltd. · Dec 2018
Ceramic Denture Zirconia Ceramics Block
K181816 · Qinhuangdao Silide Ceramic Technology Co., Ltd. · Nov 2018
K2 Zirkon Blank white classic
K173971 · Yeti Dentalprodukte GmbH · Nov 2018