FDA.reportPublic FDA data

SPEED Buccal Tube Samples

Primary DI
07540295000079
Brand
SPEED Buccal Tube Samples
Company
Hespeler Orthodontics Limited
Model
07540295000079
Published
2024-08-09
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
EJFBracket, Metal, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJFBracket, Metal, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
75402950100108PreviousGS10
07540295000079PrimaryGS10
07540295900027Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
7540295010010875402950100108
07540295000079075402950000797540295000079
07540295900027075402959000277540295900027

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic bracket, metalA metallic device that is bonded to an orthodontic band, or directly to a tooth, to hold an orthodontic wire and/or other appliance (e.g., rubber bands) used to apply pressure to the tooth in order to alter the position of the tooth. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Regulatory Flags#

DUNS number
203297635
Device count
20
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

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
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
07540295000215SPEED Tubular Supercable075402950002152024-08-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197998062346SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998062353SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998062360SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998062377SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998062384SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998062391SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998062803SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064142SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064159SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064166SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064173SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064180SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064197SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064203SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064272SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064289SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064296SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064302SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064319SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064326SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064333SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064340SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064357SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064364SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064418SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064425SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064432SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064449SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064456SolventumSolventum Orthodontics CorporationEJF2026-10-24
00197998064463SolventumSolventum Orthodontics CorporationEJF2026-10-24