MedtechSourcebook

PRIME DENTAL MANUFACTURING, INC.

Contract manufacturer ยท Chicago, IL

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

2016Product codes first listed, by year (tallest: 1)2026
FDA registration
1424442 (openFDA record; or search FDA's registration database)
FEI number
3002811563
Registered for
FDA registration year 2026
Establishment types
Manufacturer for export only; Manufacturer; Contract manufacturer
Owner or operator
PRIME DENTAL MANUFACTURING, INC. (FDA owner/operator no. 9039081)
Registered address
4555 W Addison St, Chicago, IL 60641
Contract listings
2 device listings, 2 product codes, first listed Jan 11, 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
DYHAdhesive, Bracket And Tooth Conditioner, ResinClass IIDentalContract manufacturingApr 28, 2025
EGDWax, Dental, IntraoralClass IDentalContract manufacturingJan 11, 2016