Manufacturer registered with FDA

Comfort Acrylics, Inc.

Camas, WA, United States. Lists 2 dental device types with FDA across 1 registered establishment, and holds 3 510(k) clearances as applicant.

FDA owner/operator9000294Contract manufacturerManufacturer
Device types listed
2
Brands and models
3
510(k) clearances
31990–2019
Markets registered in
21 registrations outside the US
Establishments
1United States
1990: 11991: 12019: 11990200020102020

510(k) clearances per year, 1990–2026

Registered in 2 markets

Where regulators' registries name Comfort Acrylics, Inc. as the manufacturer or the registration holder of a device.

All markets
United States: 2 device types listedCanada: 1 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerComfort Acrylics, Inc.3 clearances1990–2019Below
CanadaHealth CanadaRegistration holderCOMFORT ACRYLICS INC.11999–1999Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

Devices listed with FDA

What Comfort Acrylics, Inc. currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Anti-Snoring DeviceLRK · Class 2Anti-snoring & jaw-repositioning devicesMaker
TAP 1TAP 3
2010
Rebasing Repairing Relining Denture ResinEBI · Class 2Denture resins & teethMaker
Talon
2008

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 Comfort Acrylics, Inc. as the applicant.

Decided510(k)DeviceDevice type
11 Jan 2019K182202SLEEPAPPLRK Anti-Snoring Device
11 Jul 1991K910795COMFOR-DENT DENTURE LINEREBI Rebasing Repairing Relining Denture Resin
15 May 1990K900799COMFORT ACRYLICS PLIABLE DENTURE LINERS & SPLINTSEBI Rebasing Repairing Relining Denture Resin

Registered establishments

EstablishmentLocationWhat it does
COMFORT ACRYLICS, INC.FDA reg. 3025124CAMAS, WA, United StatesContract manufacturer, Manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9000294). 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.