MedtechSourcebook

GERGENS ORTHODONTIC LAB

Contract manufacturer · Phoenix, AZ

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

FDA registration
3008274496 (openFDA record; or search FDA's registration database)
FEI number
3008274496
Registered for
FDA registration year 2026
Establishment types
Manufacturer; Contract manufacturer
Owner or operator
Gergens Orthodontic Lab (FDA owner/operator no. 10031363)
Registered address
1745 West Deer Valley Rd, Suite 112, Phoenix, AZ 85027
Contract listings
3 device listings, 3 product codes, first listed Dec 21, 2018
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
DZCWire, OrthodonticClass IDentalContract manufacturingJul 10, 2019
LQZDevice, Jaw RepositioningClass IIDentalContract manufacturingDec 15, 2021
LRKDevice, Anti-SnoringClass IIDentalContract manufacturingDec 21, 2018