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510(k) K011491

Device
HELIOSEAL CLEAR CHROMA
Applicant
Ivoclar North America, Inc.
510(k) number
K011491
Product code
EBC
Decision
Substantially Equivalent (SESE)
Decision date
2001-08-16
Date received
2001-05-15
Regulation
872.3765
Classification name
Sealant, Pit And Fissure, And Conditioner
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
N

Applicant Contact#

Contact
ANDERJEET GULATI
Address
175 Pineview Dr. Amherst NY US 14228 14228

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EBC#

510(k), Device, Applicant table
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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