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510(k) K981965

Device
FLOWABLE COMPOSITE
Applicant
DENTSPLY INTL.
510(k) number
K981965
Product code
EMA  
Decision
Substantially Equivalent (SESE)
Decision date
1998-07-10
Date received
1998-06-04
Regulation
872.3275
Classification name
Cement, Dental
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
P. JEFFREY LEHN
Address
570 W. College Ave. P.O. Box 872 York PA US 17405 17405

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code EMA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K254201Any-CemMediclus Co., Ltd.2026-08-13
K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-Pak2026-08-07
K261166DIA-CEMDiaDent Group International2026-07-09
K254109G-CEM UNIVERSALGC America, Inc.2026-05-18
K253337REGEN Bioactive CementInter-Med, Inc.2026-04-15
K252606Bifix Veneer LC, Bifix Veneer Try-InVoco GmbH2026-03-20
K254063iCEM Universal PlusKulzer, LLC2025-12-19
K252785TopCEM Vigor SA Self-Adhesive Resin CementRizhao Huge Biomaterials Company, Ltd.2025-12-12
K252808GlasIonomer FX-LCShofu Dental Corporation2025-12-09
K252165ZIRCONOMER PShofu Dental Corporation2025-10-28
K250953EQUIA LC ONEGC America, Inc.2025-09-19
K251775RODIN CementBelport Company, Inc., Gingi-Pak2025-09-02
K250156Choice 2 DCBisco, Inc.2025-07-11
K251470ResiCem EXShofu Dental Corporation2025-07-11
K250566EsCem RMGISpident Co., Ltd.2025-06-20

Legacy Summary#

summary

FDA Review#

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