Cleared Traditional

K182350 - Dental Ceramic (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K182350 · Baot Biological Technology Co., Ltd. · Dental device
May 2019
Decision
266d
Days
Class 2
Risk

K182350 is an FDA 510(k) clearance for the Dental Ceramic. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Baot Biological Technology Co., Ltd. (Zhongshan, CN). The FDA issued a Cleared decision on May 22, 2019 after a review of 266 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.

Submission Details

510(k) Number K182350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2018
Decision Date May 22, 2019
Days to Decision 266 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 158d · This submission: 266d
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 31
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K182350.
IPS e.max Zirconia
K253953 · Ivoclar Vivadent, Inc. · Mar 2026
BruxZir® Shaded 16 PLUS
K254283 · Prismatik Dentalcraft, Inc. · Jan 2026
Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series
K253973 · Liaoning Upcera Co., Ltd. · Jan 2026
Glass Ceramic
K252789 · Shenzhen Xiangtong Co., Ltd. · Dec 2025
BruxZir® NOW
K252446 · Prismatik Dentalcraft, Inc. · Sep 2025
DenMat Multilayered Zirconia Disc
K251593 · Denmat Holding, LLC · Aug 2025