FDA.reportPublic FDA data

Ortho Shop

Primary DI
00810152071625
Brand
Ortho Shop
Company
Orthoshop, LLC
Model
8702-00
Catalog number
8702-00
Device description
Bondable Lingual Buttons Round
Published
2023-11-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00810152071625PrimaryGS10
10810152071622Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810152071625008101520716258101520716250810152071625
1081015207162210810152071622

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic power armA dental device in the shape of a straight pin or hook designed to accept an elastic band, power chain, spring, or archwire (not included), which apply a force in addition to the main orthodontic archwire, for vertical alignment and/or horizontal positioning of the teeth; it may include a base that functions as an orthodontic lock/stop. The device is typically crimped, soldered, screwed on, or inserted in the slot of an orthodontic attachment (e.g., bracket, band), or on the surface of a tooth for orthodontic traction. This is a single-patient device intended to be used for the duration of treatment (single-use) before being discarded.

Regulatory Flags#

DUNS number
129808388
Device count
10
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810152070000Mini Maxx S 1011-22-553451011-22-553452023-11-24
00810152070017Mini Maxx S 1011-22-5531011-22-5532023-11-24
00810152070024Mini Maxx S 1011-18-553451011-18-553452023-11-24
00810152070031Mini Maxx S 1011-18-5531011-18-5532023-11-24
00810152070048Lucchesi Sub-Slot2011-22-553452011-22-553452023-11-24
00810152070055ICON 3034-22-5533034-22-5532023-11-24
00810152070062ICON 3034-22-553453034-22-553452023-11-24
00810152070079Mini Maxx S 1011-22-111011-22-112023-11-24
00810152070086Mini Maxx S 1011-22-211011-22-212023-11-24
00810152070093Mini Maxx S 1011-22-121011-22-122023-11-24
00810152070109Mini Maxx S 1011-22-221011-22-222023-11-24
00810152070116Mini Maxx S 1011-22-13H1011-22-13H2023-11-24
00810152070123Mini Maxx S 1011-22-23H1011-22-23H2023-11-24
00810152070130Mini Maxx S 1011-22-14H1011-22-14H2023-11-24
00810152070147Mini Maxx S 1011-22-141011-22-142023-11-24
00810152070154Mini Maxx S 1011-22-24H1011-22-24H2023-11-24
00810152070161Mini Maxx S 1011-22-241011-22-242023-11-24
00810152070178Mini Maxx S 1011-22-15H1011-22-15H2023-11-24
00810152070185Mini Maxx S 1011-22-151011-22-152023-11-24
00810152070192Mini Maxx S 1011-22-25H1011-22-25H2023-11-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190707192976Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707192983Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707192990Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193003Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193010Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193027Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193034Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193041Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193058Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193065Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193072Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193089Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193096Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193102Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193119Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193126Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
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