Dental Device Guide
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Manufacturer registered with FDA

Acme-Monaco Corp.

New Britain, CT, United States. Lists 4 dental device types with FDA across 2 registered establishments, and holds 2 510(k) clearances as applicant.

FDA owner/operator1293141Contract manufacturerManufacturer
Device types listed
4
Brands and models
4
510(k) clearances
21990–1990
Markets registered in
757 registrations outside the US
Establishments
2United States
1990: 21990200020102020

510(k) clearances per year, 1990–2026

Registered in 7 markets

Where regulators' registries name Acme-Monaco Corp. as the manufacturer or the registration holder of a device.

All markets
United States: 4 device types listedSouth Korea: 19 registrationsCosta Rica: 18 registrationsColombia: 9 registrationsUnited Kingdom: 5 registrationsAustralia: 3 registrationsTaiwan: 3 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerAcme-Monaco Corp.2 clearances1990–1990Below
South KoreaMFDSManufacturerAcme Monaco CorporationAcme-Monaco Corporation · ACME Monaco Corporation192009–2022Pure Global AI
Costa RicaMinisterio de SaludManufacturerACME-MONACO CORP.18—Pure Global AI
ColombiaINVIMAManufacturerACME-MONACO CORPACME MONACO CORPORATION9—Pure Global AI
United KingdomMHRAManufacturerAcme Monaco Corporation5—Pure Global AI
AustraliaTGAManufacturerACME Monaco Corporation32004–2026Pure Global AI
TaiwanTFDAManufacturerAcme Monaco CorporationACME MONACO CORPORATION32014–2024Pure 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 Acme-Monaco Corp. currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Orthodontic WireDZC · Class 1Orthodontic wires & bandsMaker
MULTIPLE PRODUCTS
1992
Orthodontic Wire ClampECN · Class 1—Maker
MULTIPLE PRODUCTS
1992
Orthodontic SpringECO · Class 1Orthodontic wires & bandsMaker
MULTIPLE PRODUCTS
1992
Orthodontic Metal BracketEJF · Class 1Orthodontic bracketsMaker
MULTIPLE PRODUCTS
1992

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 Acme-Monaco Corp. as the applicant.

Decided510(k)DeviceDevice type
9 Apr 1990K895854ACME PREFORMED COATED LIGATURE TIES (TOOTH SHADE)EJF Orthodontic Metal Bracket
29 Jan 1990K895483ACME COATED ORTHODONTIC ARCHWIREEJF Orthodontic Metal Bracket

Registered establishments

EstablishmentLocationWhat it does
ACME-MONACO CORP.FDA reg. 1222301PRESQUE ISLE, ME, United StatesContract manufacturer, Manufacturer
ACME-MONACO CORP.FDA reg. 1293141NEW BRITAIN, CT, United StatesContract manufacturer, Manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 1293141). 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.