FDA.reportPublic FDA data

Mini Maxx S

Primary DI
10810152070564
Brand
Mini Maxx S
Company
Orthoshop, LLC
Model
1011-18-44
Catalog number
1011-18-44
Device description
Orthodontic Metal Brackets Mini Maxx S Brackets MBT 0.018" L4R No Hook
Published
2023-11-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
00810152070567PrimaryGS10
10810152070564Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810152070567008101520705678101520705670810152070567
1081015207056410810152070564

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
129808388
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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

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Primary DI, Brand, Company table
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00190707193119Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193126Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
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