FDA.report

Mini Maxx S

Primary DI
10810152070106
Brand
Mini Maxx S
Company
Orthoshop, LLC
Model
1011-22-22
Catalog number
1011-22-22
Device description
Orthodontic Metal Brackets Mini Maxx S Brackets MBT 0.022" U2L
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

Related Records

Product Codes

CodeName
EJFBracket, Metal, Orthodontic

Product Code Classifications

CodeDeviceSpecialtyClass
EJFBracket, Metal, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810152070109PrimaryGS10
10810152070106Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810152070109008101520701098101520701090810152070109
1081015207010610810152070106

GMDN Terms

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

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 DIBrandModelCatalogPublished
10810152070007Mini Maxx S 1011-22-553451011-22-553452023-11-24
10810152070014Mini Maxx S 1011-22-5531011-22-5532023-11-24
10810152070021Mini Maxx S 1011-18-553451011-18-553452023-11-24
10810152070038Mini Maxx S 1011-18-5531011-18-5532023-11-24
10810152070045Lucchesi Sub-Slot2011-22-553452011-22-553452023-11-24
10810152070052ICON 3034-22-5533034-22-5532023-11-24
10810152070069ICON 3034-22-553453034-22-553452023-11-24
10810152070076Mini Maxx S 1011-22-111011-22-112023-11-24
10810152070083Mini Maxx S 1011-22-211011-22-212023-11-24
10810152070090Mini Maxx S 1011-22-121011-22-122023-11-24
10810152070113Mini Maxx S 1011-22-13H1011-22-13H2023-11-24
10810152070120Mini Maxx S 1011-22-23H1011-22-23H2023-11-24
10810152070137Mini Maxx S 1011-22-14H1011-22-14H2023-11-24
10810152070144Mini Maxx S 1011-22-141011-22-142023-11-24
10810152070151Mini Maxx S 1011-22-24H1011-22-24H2023-11-24
10810152070168Mini Maxx S 1011-22-241011-22-242023-11-24
10810152070175Mini Maxx S 1011-22-15H1011-22-15H2023-11-24
10810152070182Mini Maxx S 1011-22-151011-22-152023-11-24
10810152070199Mini Maxx S 1011-22-25H1011-22-25H2023-11-24
10810152070205Mini Maxx S 1011-22-251011-22-252023-11-24

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00190746191848Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
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