FDA.reportPublic FDA data

Ligature

Primary DI
D97267022020120
Brand
Ligature
Company
Acme Monaco Corporation
Model
67-0220-2012
Device description
KOBAYSHI 012 TWIST SHORT
Published
2024-09-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
D97267022020126PrimaryHIBCC0
D97267022020120Unit 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
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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