Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1222301

FEI Number

1000121071

Entity Name

ACME-MONACO CORP.

City/State/Country

PRESQUE ISLE, ME, US

Establishment Address

1450 Central Drive, PRESQUE ISLE, ME 04769, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ACME-MONACO CORP. (Owner Number: 1293141)

Owner / Operator Contact Address

75 WINCHELL DR., --, New Britain, CT 06052, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MULTIPLE PRODUCTS MULTIPLE PRODUCTS MULTIPLE PRODUCTS Multiple

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	1992-08-06
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	1992-08-06
ECN	Clamp, Wire, Orthodontic	Dental	Class 1	872.5410	1992-08-06
DRB	Stylet, Catheter	Cardiovascular	Class 2	870.1380	2007-11-27

Official Correspondent

REBECCA KARABIN

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ACME-MONACO CORP.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007064586	Acme Monaco Asia Pte. Ltd.	Singapore Central Singapore, SG
1293141	ACME-MONACO CORP.	NEW BRITAIN, CT, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K894358	Ormco Corp.	LUMINA ORTHODONTIC BRACKET	1989-09-15
K925012	American Orthodontics	PLASTIC CHAIN	1993-09-13
K112640	Ormco Corp.	HYPERELASTIC WIRE	2011-11-16

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3023443842	HENAN BAISTRA MEDICAL DEVICES LIMITED	Zhengzhou Henan, CN
3012232878	SUNSTAR TRADING INTERNATIONAL LIMITED	Kowloon Hong Kong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1222301. Last updated year: 2026. Please use registration number 1222301 when referencing this establishment in official correspondence.