FDA.reportPublic FDA data

Twin Block

Primary DI
D82850001900
Brand
Twin Block
Company
FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC
Model
5000190
Published
2022-12-30
Public version status
Update
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
DYJRetainer, Screw Expansion, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYJRetainer, Screw Expansion, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D82850001900PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Removable dental occlusal splint, custom-madeA rigid or flexible custom-made device intended to overlay the occlusal surfaces of the teeth to maintain the position of displaced or moveable teeth, to treat teeth clenching and bruxism and their sequelae, and to provide temporary relief from muscle or temporomandibular joint (TMJ) pain (e.g., from TMJ dysfunction). It is removable by the patient (e.g., during meals), and is typically made of synthetic polymer materials and manufactured to meet the needs of an individual patient. This is a reusable device.

Sterilization Methods#

Method table
Method

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
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
D82853003370Super Screw Fixed Expander53003372022-12-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850070544849Retainer - NaturalSprintray, Inc.DYJ2026-07-29
00850070544856Retainer - BlackSprintray, Inc.DYJ2026-07-29
00850070544863Retainer - PinkSprintray, Inc.DYJ2026-07-29
00850070544870Retainer - Neon GreenSprintray, Inc.DYJ2026-07-29
08033707106616LEONE SPALEONE SPADYJ2026-07-22
08033707106623LEONE SPALEONE SPADYJ2026-07-22
08033707106630LEONE SPALEONE SPADYJ2026-07-22
08033707106647LEONE SPALEONE SPADYJ2026-07-22
08800113200210NT-TAINERSMILECADDYJ2026-07-22
06975527188057MOLEKURShanghai Coherz Technology Co., Ltd.DYJ2026-06-04
06975527188408MOLEKURShanghai Coherz Technology Co., Ltd.DYJ2026-06-04
08033707104513LEONE SPALEONE SPADYJ2026-05-28
00840456221761JMUJMU DENTAL, INCDYJ2026-05-11
00840456221778JMUJMU DENTAL, INCDYJ2026-05-11
D775AHAD0Hawley Retainer with Adams ClaspsGreat Lakes Dental Technologies, Ltd.DYJ2026-05-10
D775AHAR0Hawley Retainer with Arrow ClaspsGreat Lakes Dental Technologies, Ltd.DYJ2026-05-10
D775AHBC0Hawley Retainer with Ball ClaspsGreat Lakes Dental Technologies, Ltd.DYJ2026-05-10
D775AHCC0Hawley Retainer with Circumferential ClaspsGreat Lakes Dental Technologies, Ltd.DYJ2026-05-10
D775BMARPEL0MARPEGreat Lakes Dental Technologies, Ltd.DYJ2026-05-10
D775BMARPEP0MARPEGreat Lakes Dental Technologies, Ltd.DYJ2026-05-10
D775BMMT0MemotainGreat Lakes Dental Technologies, Ltd.DYJ2026-05-10
00197998216633Clarity™Solventum Orthodontics CorporationDYJ2026-04-25
10371347023326Advance Dental ProductsThe Atlanta Dental Supply CompanyDYJ2026-04-14
10371347023333Advance Dental ProductsThe Atlanta Dental Supply CompanyDYJ2026-04-14
10371347023340Advance Dental ProductsThe Atlanta Dental Supply CompanyDYJ2026-04-14
10371347023357Advance Dental ProductsThe Atlanta Dental Supply CompanyDYJ2026-04-14
D775AEA0Expansion ApplianceGreat Lakes Dental Technologies, Ltd.DYJ2026-04-13
D775AH0Hawley RetainerGreat Lakes Dental Technologies, Ltd.DYJ2026-04-13
D775BKS0Keles SliderGreat Lakes Dental Technologies, Ltd.DYJ2026-04-13
00190746202766PowerScopeAMERICAN ORTHODONTICS CORPORATIONDYJ2026-04-08