MedtechSourcebook

PRISMATIK DENTALCRAFT, INC.

Contract manufacturer · Irvine, CA

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

FDA registration
3011649314 (openFDA record; or search FDA's registration database)
FEI number
3011649314
Registered for
FDA registration year 2026
Establishment types
Complaint file establishment; Specification developer; Manufacturer; Contract manufacturer; Repackager or relabeler
Owner or operator
PRISMATIK DENTALCRAFT, INC. (FDA owner/operator no. 10043585)
Registered address
2144 Michelson Drive, Irvine, CA 92612
Contract listings
8 device listings, 2 product codes, first listed Mar 1, 2013
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
LRKDevice, Anti-SnoringClass IIDentalContract manufacturingMar 1, 2013
NHAAbutment, Implant, Dental, EndosseousClass IIDentalContract manufacturingFeb 21, 2024