MedtechSourcebook

PRU-DENT MFG., INC.

Contract manufacturer · Schaumburg, IL

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

FDA registration
1419247 (openFDA record; or search FDA's registration database)
FEI number
1419247
Registered for
FDA registration year 2026
Establishment types
Manufacturer; Contract manufacturer; Remanufacturer; Repackager or relabeler
Owner or operator
TIM J. PRUSAITIS (FDA owner/operator no. 1419247)
Registered address
1929 WRIGHT BLVD., Schaumburg, IL 60193
Contract listings
9 device listings, 9 product codes, first listed Dec 15, 2016
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
DZNInstruments, Dental HandClass IDentalContract manufacturingSep 19, 2023
EKBExplorer, OperativeClass IDentalContract manufacturingDec 15, 2016
EKCExcavator, Dental, OperativeClass IDentalContract manufacturingDec 15, 2016
EKJBurnisher, OperativeClass IDentalContract manufacturingDec 15, 2016
EMIFile, Bone, SurgicalClass IDentalContract manufacturingDec 15, 2016
EMKCurette, Surgical, DentalClass IDentalContract manufacturingDec 15, 2016
EMNScaler, PeriodonticClass IDentalContract manufacturingDec 15, 2016
EMOKnife, PeriodonticClass IDentalContract manufacturingDec 15, 2016
EMSCurette, PeriodonticClass IDentalContract manufacturingSep 19, 2023