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510(k) K150432

Device
IDODENTINE DISC, IDODENTINE BLOCK
Applicant
UNION DENTAL S.A.
510(k) number
K150432
Product code
EBG  
Decision
Substantially Equivalent (SESE)
Decision date
2015-08-14
Date received
2015-02-19
Regulation
872.3770
Classification name
Crown And Bridge, Temporary, Resin
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JOSE LUIS RODRIGUEZ BLANCO
Address
Paseo De La Estacion, 4. Tielmes ES 28550 28550

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code EBG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261261Dura-ArchHangzhou SHINING3D Dental Technology Co., Ltd.2026-04-17
K253380“FLNT Base” and “FLNT Temp”Liaoning Upcera Co., Ltd.2026-03-02
K251271TempFIT Temporary Crown and Bridge ResinRizhao Huge Biomaterials Company, Ltd.2025-06-23
K243370DentaTOOTHAsiga Pty, Ltd.2025-05-05
K243621Evoblock, PerléonEvoden Indústria Comércio Importação E Exportação2025-04-22
K243951TEMP MASTER, PMMA-based dental resinTaiwan Dental Materials Co., Ltd.2025-02-21
K242559Digital TempSprintray, Inc.2024-11-26
K231859PrimmaArtDentscare Ltda2024-11-26
K240538Premium Teeth ResinFormlabs Ohio, Inc.2024-07-19
K241226Fixtemp® C&B 4:1Dreve Denatmid GmbH2024-05-31
K233868dima Print Teeth & TempKulzer, LLC2024-05-23
K223706PMMA BLOCKHuliang(Shanghai) Bio-Tech Co., Ltd.2023-05-12
K223477PMMA Blocks for Dental UseAidite (Qinhuangdao) Technology Co., Ltd.2023-02-16
K202965CURA-TempMgnewton , Ltd.2022-12-21
K214071Hexa-TempSpident Co., Ltd.2022-03-10

Legacy Summary#

summary

FDA Review#

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