FDA.report

Infinitas Orthodontic Mini Implant

Primary DI
05056091026851
Brand
Infinitas Orthodontic Mini Implant
Company
DB ORTHODONTICS LIMITED
Model
Infinitas M/I L6mm, D2mm, N2.5 Round Head
Catalog number
DB10-0019
Device description
Infinitas Orthodontic Mini Implant L6mm, D2mm, N2.5mm Round Neck - Sterile
Published
2025-08-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
OATImplant, Endosseous, Orthodontic

Product Code Classifications

CodeDeviceSpecialtyClass
OATImplant, Endosseous, OrthodonticDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05056091026851PrimaryGS10

GMDN Terms

TermDefinition
Orthodontic anchoring screwA small, metallic, implantable rod with a spiral thread and slotted/formed head that is inserted into the bone of the jaw to serve as a temporary anchor for an orthodontic device (e.g., a spring or plate). It is available in various sizes and lengths, and may have a self-drilling/self-tapping thread for easy insertion and removal after desired alignment of the teeth. It is used in a variety of orthodontic treatment situations, especially when normal anatomy has been compromised (e.g., due to periodontal disease or agenesis, displacement of teeth in the same direction, asymmetrical anatomy). This is a single-use device.

Device Sizes

TypeValueUnit
Length6Millimeter
Outer Diameter2Millimeter

Sterilization Methods

Method

Contacts

PhoneEmail
+441535650571anna.dyson@dbortho.com

Regulatory Flags

DUNS number
213136229
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
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
05056091028602Infinitas Orthodontic Mini ImplantInfinitas M/I L9mm, D1.5mm, N2.5 Round HeadDB10-00182025-08-13
05060429400008Infinitas Orthodontic Mini ImplantInfinitas M/I L6mm, D1.5mm S/N DB10-00012016-09-25
05060429400015Infinitas Orthodontic Mini ImplantInfinitas M/I L9mm, D1.5mm S/NDB10-00022016-09-25
05060429400022Infinitas Orthodontic Mini ImplantInfinitas M/I L9mm, D1.5mm L/NDB10-00042016-09-25
05060429400039Infinitas Orthodontic Mini ImplantInfinitas M/I L6mm, D2.0mm L/NDB10-00072016-09-25
05060429400046Infinitas Orthodontic Mini ImplantInfinitas M/I L9mm, D2.0mm L/NDB10-00082016-09-25
05060429400053Infinitas Orthodontic Mini ImplantInfinitas M/I L6mm, D1.5mm, N1.5mm DB10-00092016-09-25
05060429400060Infinitas Orthodontic Mini ImplantInfinitas M/I L9mm, D1.5mm, N1.5mm DB10-00102016-09-25
05060429400077Infinitas Orthodontic Mini ImplantInfinitas M/I L9mm, D1.5mm, N2.5mm DB10-00122016-09-25
05060429400084Infinitas Orthodontic Mini ImplantInfinitas M/I L6mm, D2.0mm, N2.5mm DB10-00152016-09-25
05060429400091Infinitas Orthodontic Mini ImplantInfinitas M/I L9mm, D2.0mm, N2.5mm DB10-00162016-09-25

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