Cleared Traditional

K240586 - Additive Manufacturing Zirconia Customized Restoration (FDA 510(k) Clearance)

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

K240586 · Hangzhou Thales Medtech Co., Ltd. · Dental device
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Oct 2024
Decision
216d
Days
Class 2
Risk

K240586 is an FDA 510(k) clearance for the Additive Manufacturing Zirconia Customized Restoration. Classified as Teeth, Porcelain (product code ELL), Class II - Special Controls.

Submitted by Hangzhou Thales Medtech Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on October 3, 2024 after a review of 216 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3920 - 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 Hangzhou Thales Medtech Co., Ltd. devices

Submission Details

510(k) Number K240586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2024
Decision Date October 03, 2024
Days to Decision 216 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
89d slower than avg
Panel avg: 127d · This submission: 216d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ELL Teeth, Porcelain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3920
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 Consultant

Beijing Xinranyicheng Medicine & Technology Co., Ltd.
Chen Kaimin

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.