FDA.reportPublic FDA data

Digital Indirect Bond

Primary DI
D8285401650
Brand
Digital Indirect Bond
Company
FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC
Model
540165
Published
2022-12-12
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
QJJIndirect Bonding Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QJJIndirect Bonding TrayDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D8285401650PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic appliance/positioning tray kitA collection of dental devices which includes a custom-made positioning tray (indirect bonding tray) intended to position and hold in place a set of included orthodontic appliances (e.g., brackets, buccal tubes, lingual retainers) to bond them to teeth during a single procedure. The components are typically made of synthetic polymer and/or metal materials and include appliances manufactured from an oral cavity impression or oral scan for a specific patient (custom-made). This is a single-use 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
10850061082029Custom Orthodontic SolutionKlowen Braces, Inc.QJJ2026-05-26
06956748704417Angel AlignerWuxi EA Medical Instruments Technologies Limited.QJJ2026-05-19
D9821716150LuxaPrint Ortho Flex NXDMG Digital Enterprises SEQJJ2026-05-06
D9821716160LuxaPrint Ortho Flex NXDMG Digital Enterprises SEQJJ2026-05-06
D9821716170LuxaPrint Ortho Flex NXDMG Digital Enterprises SEQJJ2026-05-06
D9821716180LuxaPrint Ortho Flex NXDMG Digital Enterprises SEQJJ2026-05-06
D9821716190LuxaPrint Ortho Flex NXDMG Digital Enterprises SEQJJ2026-05-06
00850070544832IDB 3 Sprintray, Inc.QJJ2026-03-17
00860012928408CelebraceCelebrace Inc.QJJ2025-03-28
00850061082015Custom Digital OrthodonticsKlowen Braces, Inc.QJJ2024-11-21
09359215000055DentaIBTASIGA PTY LTDQJJ2024-02-06
D865REF06001ClearCorrect System Engager TemplateClearcorrect Operating, LLCQJJ2024-02-02
07290018915028MED610STRATASYS LTDQJJ2024-01-10
07290018915219MED610STRATASYS LTDQJJ2024-01-10
07290018915417MED610STRATASYS LTDQJJ2024-01-10
07290018915615MED610STRATASYS LTDQJJ2024-01-10
07290018915813MED610STRATASYS LTDQJJ2024-01-10
D865REF02001ClearCorrect SystemClearcorrect Operating, LLCQJJ2023-08-25
00816063022169Attachment TemplateAlign Technology, Inc.QJJ2023-07-24
D82854001600Indirect BondFIVE STAR ORTHODONTIC LABORATORY & SUPPLY INCQJJ2022-12-12
D82854001610Indirect Bond W/Hard ShellFIVE STAR ORTHODONTIC LABORATORY & SUPPLY INCQJJ2022-12-12
D82854001660Indirect Bond-EZ_HardSoftFIVE STAR ORTHODONTIC LABORATORY & SUPPLY INCQJJ2022-12-12
D918DOCWT0Digital Orthodontic CareDigital Orthodontic CareQJJ2022-12-09
H66842000081KeyPrintKeystone IndustriesQJJ2022-11-30
H66842200081KeyPrintKeystone IndustriesQJJ2022-11-30
D9821712500LuxaPrint Ortho Flex 385DMG Digital Enterprises SEQJJ2022-09-01
D9821712510LuxaPrint Ortho Flex 385DMG Digital Enterprises SEQJJ2022-09-01
D9821712520LuxaPrint Ortho Flex 385DMG Digital Enterprises SEQJJ2022-09-01
D9821712530LuxaPrint Ortho Flex 385DMG Digital Enterprises SEQJJ2022-09-01
D9821712730LuxaPrint Ortho Flex 385DMG Digital Enterprises SEQJJ2022-09-01