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510(k) K091635

Device
VENUS DIAMOND FLOW
Applicant
HERAEUS KULZER, LLC
510(k) number
K091635
Product code
EBC  
Decision
Substantially Equivalent (SESE)
Decision date
2009-09-03
Date received
2009-06-04
Regulation
872.3765
Classification name
Sealant, Pit And Fissure, And Conditioner
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Abbreviated
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
CHERYL ZIMMERMAN
Address
300 Heraeus Way South Bend IN US 46614 46614

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code EBC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260819Any-Com SealMediclus Co., Ltd.2026-05-01
K243254Parkell Pit and Fissure SealantParkell, Inc.2025-08-08
K232498UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by NobioUltradent Product, Inc.2023-08-18
K230455Enamel Coating ResinRizhao Huge Biomaterials Company, Ltd.2023-07-25
K190998BA Pit & Fissure SealantApex Dental Materials, Inc.2019-11-08
K190339Helioseal F PlusIvoclar Vivadent, AG2019-07-29
K172169Pulpdent (Activa) Pit and Fissure Sealant with MCPPulpdent Corporation2018-01-05
K171330Nanova SealantNanova Biomaterials, Inc.2017-09-08
K162598HAPI SealBisco, Inc.2017-05-23
K161580Premier SealantPremier Dental Company Products2016-10-18
K141717PACSEAL PIT & FISSURE SEALANTPac-Dent International, Inc.2015-03-09
K130485CONTROL SEALVoco GmbH2014-02-11
K122521PREVENT SEALItena Clinical2013-06-11
K113818EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILLPulpdent Corporation2012-03-21
K112517ULTRASEAL XT HYDROUltradent Products, Inc.2011-09-23

Legacy Summary#

summary

FDA Review#

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