Home / 510(k) Clearances / K240586

510(k) K240586

Additive Manufacturing Zirconia Customized Restoration by Hangzhou Thales Medtech Co., Ltd. — Product Code ELL

K240586 is an FDA 510(k) premarket notification submitted by Hangzhou Thales Medtech Co., Ltd. for the device "Additive Manufacturing Zirconia Customized Restoration". The FDA issued a decision of Substantially Equivalent on October 3, 2024. The device falls under product code ELL (Teeth, Porcelain), a Class II device regulated under 21 CFR 872.3920.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 2024
Date Received
March 1, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Teeth, Porcelain
Device Class
Class II
Regulation Number
872.3920
Review Panel
DE
Submission Type

Other clearances for product code ELL

  • K203072 — Franz Zirconia Dental Crown (January 19, 2022)
  • K162043 — NobelProcera HT ML FCZ Bridge (November 22, 2016)
  • K153534 — NobelProcera HT ML Full Contour Zirconia Crown (June 6, 2016)
  • K071182 — PROCERA BRIDGE ZIRCONIA 9 UNITS-14 UNITS, MODELS 30-4004 TO 30-4013 (July 11, 2007)
  • K060530 — SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING F (May 22, 2006)
  • K041283 — PROCERA BRIDGE ZIRCONIA (May 28, 2004)
  • K032562 — PROCEARA COPINGS AND PONTIC (February 6, 2004)
  • K965216 — ARGI-SATIN OR OPTI0-STAR (February 27, 1997)
  • K960770 — MATCHMAKER/PROPAQUE PORCELAIN (November 19, 1996)
  • K960480 — IN-CERAM SPINELL KIT FOR CELAV MODEL V56-001/E63013 (March 15, 1996)

FDA data resources