Not currently registered with FDA under this name

Pemaco, Inc.

Fenton, MO, United States. Named as applicant on 7 dental 510(k) clearances between 1989 and 1991. No establishment is registered with FDA under this exact name today.

Device types listed: 0
Brands and models: 0
510(k) clearances: 71989–1991
Markets registered in: 22 registrations outside the US
Establishments: 0—

510(k) clearances per year, 1980–2026

Registered in 2 markets

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

All markets

RegisteredHome: United StatesOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Applicant	Pemaco, Inc.	7 clearances	1989–1991	Below
South Korea	MFDS	Manufacturer	Pemaco Inc.	2	2010–2010	Pure 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

510(k) clearances

Clearances on which FDA names Pemaco, Inc. as the applicant.

Decided	510(k)	Device	Device type
21 Aug 1991	K910676	INTRAORAL DENTAL WAX	EGD Intraoral Dental Wax
6 Nov 1989	K895566	PEMACO ECONOMY BASE PLATE WAX-MEDIUM SOFT	EGD Intraoral Dental Wax
6 Nov 1989	K895564	PEMACO BITE BLOCK RODS-MEDIUM SOFT & MEDIUM HARD	EGD Intraoral Dental Wax
6 Nov 1989	K895563	PEMACO BITE WAX SHEETS	EGD Intraoral Dental Wax
6 Nov 1989	K895562	PEMACO 2000 INTRAORAL DENTAL WAX	EGD Intraoral Dental Wax
6 Nov 1989	K895561	PEMACO 3000 INTRAORAL DENTAL WAX	EGD Intraoral Dental Wax
24 Oct 1989	K895565	PEMACO ECONOMY BASE PLATE WAX-MEDIUM HARD	EGD Intraoral Dental Wax

Some of these clearances are listed with FDA today by another company: Garreco, LLC. (7).

Sources

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 of the most recent filing, which can be a US agent.