510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K240586Substantially Equivalent

Additive Manufacturing Zirconia Customized Restoration

Hangzhou Thales MedTech Co., Ltd., Hangzhou, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K240586 is the FDA 510(k) clearance record for Additive Manufacturing Zirconia Customized Restoration, a class II device, cleared for Hangzhou Thales Medtech Co., Ltd. on under FDA product code ELL (Teeth, Porcelain). FDA records list one 510(k) clearance for Hangzhou Thales Medtech Co., Ltd. As of , FDA records show no recalls naming K240586.

Clearance record

Decision date
Received
(216 days to decision)
Product code
ELL Teeth, Porcelain
Regulation
21 CFR 872.3920
Device class
Class II
Review panel
Dental
Applicant
Hangzhou Thales Medtech Co., Ltd. 1001 Rm. 3# First Floor, 1building, 8 Block, Hangzhou, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ELL

Trailing 12 months

FDA records hold no clearances under product code ELL in the trailing twelve months.

FDA records show no clearances under product code ELL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ELL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260