Manufacturer registered with FDA

Perma Laboratories

Hinckley, OH, United States. Lists 3 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator9006672ManufacturerRepacker / relabeler
Device types listed
3
Brands and models
4
510(k) clearances
12012–2012
Markets registered in
1United States
Establishments
1United States
2012: 120102020

510(k) clearances per year, 2007–2026

Devices listed with FDA

What Perma Laboratories currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Over the Counter Denture RelinerEBP · Class 2—Maker
Perma Soft Denture RelinerProSoft Denture Reliner
2007
Denture Repair KitEBO · Class 2—Lister
P.E.R.K.
2007
Over the Counter Denture CleanserEFT · Class 1Denture cleansers & adhesivesLister
Fizz-It Denture Cleaner
2018

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names Perma Laboratories as the applicant.

Decided510(k)DeviceDevice type
6 Jun 2012K121318PROSOFTEBP Over the Counter Denture Reliner

Registered establishments

EstablishmentLocationWhat it does
PERMA LABORATORIESFDA reg. 1528710Hinckley, OH, United StatesComplaint file establishment, Manufacturer, Repacker / relabeler

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9006672). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.