FDA.reportPublic FDA data

SPEED D-Wire - Nickel Titanium

Primary DI
07540295900065
Brand
SPEED D-Wire - Nickel Titanium
Company
Hespeler Orthodontics Limited
Model
07540295000130
Published
2024-08-09
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

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
75402950300034PreviousGS10
07540295000130PrimaryGS10
07540295900065Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
7540295030003475402950300034
07540295000130075402950001307540295000130
07540295900065075402959000657540295900065

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

Regulatory Flags#

DUNS number
203297635
Device count
10
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
07540295000017SPEED Bracket075402950000172024-08-09
07540295000024SPEED Bracket075402950000242024-08-09
07540295000031SPEED Bracket075402950000312024-08-09
07540295000048SPEED Buccal Tube075402950000482024-08-09
07540295000055SPEED Buccal Tube075402950000552024-08-09
07540295000062SPEED Buccal Tube075402950000622024-08-09
07540295000079SPEED Buccal Tube Samples075402950000792024-08-09
07540295000086SPEED Convertible Buccal Tube075402950000862024-08-09
07540295000093SPEED Convertible Buccal Tube075402950000932024-08-09
07540295000109SPEED Convertible Buccal Tube075402950001092024-08-09
07540295000116SPEED Beta Titanium Archwire075402950001162024-08-09
07540295000123SPEED Coaxial Archwire075402950001232024-08-09
07540295000130SPEED D-Wire - Nickel Titanium075402950001302024-08-09
07540295000147SPEED D-Wire - Stainless Steel075402950001472024-08-09
07540295000154Hills Dual-Geometry Wire075402950001542024-08-09
07540295000161Round Nickel Titanium Archwire075402950001612024-08-09
07540295000178SPEED Wire - Nickel Titanium075402950001782024-08-09
07540295000185SPEED Wire - Stainless Steel075402950001852024-08-09
07540295000192SPEED Supercable075402950001922024-08-09
07540295000208SPEED Lingual Supercable075402950002082024-08-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190746202841Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202858Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202865Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202872Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202889Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202896Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202902Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202919Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202926Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202933Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202940Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202957Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202964Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202971Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202988Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202995Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746203008Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746203015Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746203022Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746203039Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746203046Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746203053Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746203060Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746203077Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746203084Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746203091Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746203107Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746203114Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746203121Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746203138Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29