FDA.reportPublic FDA data

Orthodontic wire

Primary DI
08806145484635
Brand
Orthodontic wire
Company
DENTOS Inc.
Model
ND-18X18-TU
Published
2018-08-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
08806145484635PrimaryGS10
08806145475398Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806145484635088061454846358806145484635
08806145475398088061454753988806145475398

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
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
688355973
Device count
10
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08806145440129Orthodontic DriverLHD-B+DT-L2025-05-02
08806145440136Orthodontic DriverLHD-B+DT-S2025-05-02
08806145440143Orthodontic DriverNLHD+ST-L2025-05-02
08806145440150Orthodontic DriverNLHD+ST-S2025-05-02
08806145440167Orthodontic DriverNLHD-S+ST-L2025-05-02
08806145440174Orthodontic DriverNLHD-S+ST-S2025-05-02
08806145484086Orthodontic DriverNLHD-S2025-05-02
08806145484895Plier, OrthodonticNTDP-T2025-05-02
08806145484901Plier, OrthodonticNTDP-S2025-05-02
08806145484918Plier, OrthodonticCBRP2025-05-02
08806145455192Orthodontic BracketMTB-12018-09-14
08806145455208Orthodontic BracketMTB-22018-09-14
08806145455215Orthodontic BracketTLB-L2018-09-14
08806145455222Orthodontic BracketTLB-U2018-09-14
08806145471352Orthodontic Bracket2in1-U-122018-06-08
08806145471369Orthodontic Bracket2in1-U-32018-06-08
08806145471376Orthodontic Bracket2in1-U-4572018-06-08
08806145471383Orthodontic Bracket2in1-U-62018-06-08
08806145471390Orthodontic Bracket2in1-L-1232018-06-08
08806145471406Orthodontic Bracket2in1-L-4572018-06-08

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