Cleared Traditional

K240586 - Additive Manufacturing Zirconia Customi...

K240586 is an FDA 510(k) clearance for Additive Manufacturing Zirconia Customi..., manufactured by Hangzhou Thales Medtech Co., Ltd.. The device is a Class 2 Dental device with product code ELL cleared through the Traditional 510(k) pathway after a 216-day FDA review.

K240586 · Hangzhou Thales Medtech Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K240586

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.

ELL Device Classification - Class 2, Special Controls

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.

Regulatory Peers - ELL Teeth, Porcelain

All 29
Devices cleared under the same product code (ELL) and FDA review panel - the closest regulatory comparables to K240586.
Franz Zirconia Dental Crown
K203072 · Franz Biotech, Inc. · Jan 2022
NobelProcera HT ML FCZ Bridge
K162043 · Nobel Biocare AB · Nov 2016
NobelProcera HT ML Full Contour Zirconia Crown
K153534 · Nobel Biocare AB · Jun 2016
PROCERA BRIDGE ZIRCONIA 9 UNITS-14 UNITS, MODELS 30-4004 TO 30-4013
K071182 · Nobel Biocare AB · Jul 2007
SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302.
K060530 · Lifecore Biomedical, Inc. · May 2006
PROCERA BRIDGE ZIRCONIA
K041283 · Nobel Biocare AB · May 2004