Cleared Traditional

K181496 - VINTAGE PRO

K181496 is an FDA 510(k) clearance for VINTAGE PRO, 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 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

FDA 510(k) Submission Details - K181496

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.

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 401
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