Cleared Traditional

K182350 - Dental Ceramic

K182350 is the FDA 510(k) clearance for Dental Ceramic by Baot Biological Technology Co., Ltd.. It is a Class 2 Dental device (product code EIH) cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K182350 · Baot Biological Technology Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Baot Biological Technology Co., Ltd. devices

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
139d slower than avg
Panel avg: 127d · 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

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