FDA.reportPublic FDA data

Archwire

Primary DI
D972AMC1825UNBTNE2
Brand
Archwire
Company
Acme Monaco Corporation
Model
AMC1825UNBTNE
Device description
18x25 Beta Titan - Nat - U
Published
2023-03-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZCWire, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZCWire, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D972AMC1825UNBTNE2PrimaryHIBCC0
AMC1825UNBTNE0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic archwireA dental wire in the shape of an arch used with orthodontic attachments (orthodontic brackets) that are affixed to the crowns/surfaces of two or more teeth in order to cause/guide tooth movement. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8602241349acmecorp@acmemonaco.com

Regulatory Flags#

DUNS number
118370238
Device count
10
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D972AMC1616LGRST2ArchwireAMC1616LGRST2024-09-20
D972AMC1818UNAT2ArchwireAMC1818UNAT2024-09-20
D972AMC1925LMRGM2ArchwireAMC1925LMRGM2024-09-20
D972AMC1030NTI150SpringAMC1030NTI15/#32024-09-20
D972AMC1616LGRST0ArchwireAMC1616LGRST2024-09-20
D972AMC1818UNAT0ArchwireAMC1818UNAT2024-09-20
D972AMC1925LMRGM0ArchwireAMC1925LMRGM2024-09-20
D97267022020126Ligature67-0220-20122024-09-17
D97277G0L200162Archwire 77-G0L2-00162024-09-17
D97277G0L200182Archwire 77-G0L2-00182024-09-17
D97277G0L216222Archwire 77-G0L2-16222024-09-17
D97277G0L217252Archwire 77-G0L2-17252024-09-17
D97277G0L218252Archwire 77-G0L2-18252024-09-17
D97277G0L219252Archwire 77-G0L2-19252024-09-17
D97277G0U200162Archwire 77-G0U2-00162024-09-17
D97277G0U200182Archwire 77-G0U2-00182024-09-17
D97277G0U216222Archwire 77-G0U2-16222024-09-17
D97277G0U217252Archwire 77-G0U2-17252024-09-17
D97277G0U218252Archwire 77-G0U2-18252024-09-17
D97277G0U219252Archwire 77-G0U2-19252024-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456209882JMUJMU DENTAL, INCDZC2026-06-25
00840456209899JMUJMU DENTAL, INCDZC2026-06-25
00840456209905JMUJMU DENTAL, INCDZC2026-06-25
00840456209912JMUJMU DENTAL, INCDZC2026-06-25
00840456209929JMUJMU DENTAL, INCDZC2026-06-25
00840456209936JMUJMU DENTAL, INCDZC2026-06-25
00840456209943JMUJMU DENTAL, INCDZC2026-06-25
00840456209950JMUJMU DENTAL, INCDZC2026-06-25
00840456209967JMUJMU DENTAL, INCDZC2026-06-25
00840456209974JMUJMU DENTAL, INCDZC2026-06-25
00840456209981JMUJMU DENTAL, INCDZC2026-06-25
00840456209998JMUJMU DENTAL, INCDZC2026-06-25
00840456210000JMUJMU DENTAL, INCDZC2026-06-25
00840456210017JMUJMU DENTAL, INCDZC2026-06-25
00840456210024JMUJMU DENTAL, INCDZC2026-06-25
00840456210031JMUJMU DENTAL, INCDZC2026-06-25
00840456210048JMUJMU DENTAL, INCDZC2026-06-25
00840456210055JMUJMU DENTAL, INCDZC2026-06-25
00840456210062JMUJMU DENTAL, INCDZC2026-06-25
00840456210079JMUJMU DENTAL, INCDZC2026-06-25
00840456210086JMUJMU DENTAL, INCDZC2026-06-25
00840456210093JMUJMU DENTAL, INCDZC2026-06-25
00840456210109JMUJMU DENTAL, INCDZC2026-06-25
00840456210116JMUJMU DENTAL, INCDZC2026-06-25
00840456210123JMUJMU DENTAL, INCDZC2026-06-25
00840456210130JMUJMU DENTAL, INCDZC2026-06-25
00840456211182JMUJMU DENTAL, INCDZC2026-06-25
00840456211199JMUJMU DENTAL, INCDZC2026-06-25
00840456211205JMUJMU DENTAL, INCDZC2026-06-25
00840456211212JMUJMU DENTAL, INCDZC2026-06-25