FDA.reportPublic FDA data

Tandem Traction Bow

Primary DI
D82854003090
Brand
Tandem Traction Bow
Company
FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC
Model
5400309
Published
2022-12-09
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
DZCWire, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZCWire, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D82854003090PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic palate expander/teeth aligner, self-removableAn orthodontic device intended to gradually spread the maxillary arch and/or improve teeth alignment. It is typically in the form of either: 1) a segmented body separated by a palate expander screw; or 2) a spring-like mechanism with clasps and/or wires. It is not fixed to the oral cavity so that it can be temporarily removed and reapplied by the patient during the treatment period (e.g., for eating). This is a reusable device.

Regulatory Flags#

DUNS number
113352686
Device count
1
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D82850001900Twin Block50001902022-12-30
D82853004020Rickonator53004022022-12-09
D82851006000Tri-Aligner51006002023-02-13
D82851001560Bioliner Plus51001562023-02-10
D82850001910Removable Rickonator50001912023-01-13
D82853003720LVI Anterior Remodeling Appliance53003722023-01-13
D82852000100Incisor Blocks52000102023-01-03
D82853003010Snap Fit RPE53003012022-12-28
D82853000300Distal Shoe Space Maintainer53000302022-12-13
D82853002850Self-Activating Memory RPE53002852022-12-13
D82853002890Memory RPE53002892022-12-13
D82853002930RPE53002932022-12-13
D82853002950Skeletal Expander53002952022-12-13
D82853002980Bilateral Leone Distalizer53002982022-12-13
D82853002990Unilateral Expander53002992022-12-13
D82853003000Bondable R.P.E. - No Bands53003002022-12-13
D82853003110Haas Appliance53003112022-12-13
D82853003330Five Star Fixed Expander - Upper53003332022-12-13
D82853003340Five Star Mixed Dent Expander- Upper53003342022-12-13
D82853003350Five Star Mixed Dent Expander- Lower53003352022-12-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
J011520120000Noninium®DENTAURUM GmbH & Co.KGDZC2026-09-04
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