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510(k) K240586

Device
Additive Manufacturing Zirconia Customized Restoration
Applicant
Hangzhou Thales Medtech Co., Ltd.
510(k) number
K240586
Product code
ELL
Decision
Substantially Equivalent (SESE)
Decision date
2024-10-03
Date received
2024-03-01
Regulation
872.3920
Classification name
Teeth, Porcelain
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Wang Shuo
Address
1001 Rm. 3# First Floor, 1building, 8 Block Zhuantang Technological And Economic Zone, Xihu District Hangzhou CN 310000 310000

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code ELL#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K203072Franz Zirconia Dental CrownFranz Biotech, Inc.2022-01-19
K162043NobelProcera HT ML FCZ BridgeNobel Biocare AB2016-11-22
K153534NobelProcera HT ML Full Contour Zirconia CrownNobel Biocare AB2016-06-06
K071182PROCERA BRIDGE ZIRCONIA 9 UNITS-14 UNITS, MODELS 30-4004 TO 30-4013Nobel Biocare AB2007-07-11
K060530SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302.Lifecore Biomedical, Inc.2006-05-22
K041283PROCERA BRIDGE ZIRCONIANobel Biocare AB2004-05-28
K032562PROCEARA COPINGS AND PONTICNobel Biocare AB2004-02-06
K965216ARGI-SATIN OR OPTI0-STARArgen Precious Metals, Inc.1997-02-27
K960770MATCHMAKER/PROPAQUE PORCELAINDavis Schottlander & Davis, Ltd.1996-11-19
K960480IN-CERAM SPINELL KIT FOR CELAV MODEL V56-001/E63013Vident1996-03-15
K930835VIVOPERL-PE, VIVAPERL-PE ORTHOTYP/ORTHOTYP AIvoclar North America, Inc.1994-07-22
K932012CAPSChemichl, Inc.1993-11-03
K931808DUCERAGOLD, DUCERATINDegussa AG1993-11-03
K924823MICRODOSE SILANEUnicep1993-03-16
K924821MICRODOSE PORCELAIN ETCHANTUnicep1993-03-16