Cleared Traditional

K192231 - Dental Glass Ceramics Blocks (FDA 510(k) Clearance)

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

K192231 · Aidite (Qinhuangdao) Technology Co., Ltd. · Dental device
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Jul 2020
Decision
327d
Days
Class 2
Risk

K192231 is an FDA 510(k) clearance for the Dental Glass Ceramics Blocks. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Aidite (Qinhuangdao) Technology Co., Ltd. (Qinhuangdao, CN). The FDA issued a Cleared decision on July 8, 2020 after a review of 327 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Aidite (Qinhuangdao) Technology Co., Ltd. devices

Submission Details

510(k) Number K192231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2019
Decision Date July 08, 2020
Days to Decision 327 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
200d slower than avg
Panel avg: 127d · This submission: 327d
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 478
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