MedtechSourcebook

Ivoclar Vivadent Manufacturing, Inc

Contract manufacturer ยท Somerset, NJ

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

1982Product codes first listed, by year (tallest: 4)2026
FDA registration
2244842 (openFDA record; or search FDA's registration database)
FEI number
2244842
Registered for
FDA registration year 2026
Establishment types
Contract manufacturer; Repackager or relabeler
Owner or operator
IVOCLAR VIVADENT (FDA owner/operator no. 8010208)
Registered address
500 MEMORIAL DR., Somerset, NJ 08873
Contract listings
35 device listings, 11 product codes, first listed Feb 10, 1982
Certification
Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.

Product codeDevice (FDA name)ClassCategoryRoleFirst listed
EBCSealant, Pit And Fissure, And ConditionerClass IIDentalContract manufacturingJul 30, 2019
EBFMaterial, Tooth Shade, ResinClass IIDentalContract manufacturingFeb 10, 1982
EBGCrown And Bridge, Temporary, ResinClass IIDentalContract manufacturingMar 13, 2013
EBIResin, Denture, Relining, Repairing, RebasingClass IIDentalContract manufacturingAug 13, 2015
EGDWax, Dental, IntraoralClass IDentalContract manufacturingJan 31, 2007
EIHPowder, PorcelainClass IIDentalContract manufacturingNov 14, 2007
ELMDenture, Plastic, TeethClass IIDentalContract manufacturingMay 19, 2016
EMACement, DentalClass IIDentalContract manufacturingAug 22, 2013
KLEAgent, Tooth Bonding, ResinClass IIDentalContract manufacturingNov 15, 2007
LBHVarnish, CavityClass IIDentalContract manufacturingNov 14, 2007
NHAAbutment, Implant, Dental, EndosseousClass IIDentalContract manufacturingNov 5, 2013