FDA.report

ORLUS MINI SCREW

Primary DI
08809283890467
Brand
ORLUS MINI SCREW
Company
ORTHOLUTION CO.,LTD.
Model
1H18108
Catalog number
1H18108
Published
2015-12-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications

CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08809283890474PackageGS12In Commercial Distribution
08809283890467PrimaryGS10

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
Outer Diameter1.8Millimeter

Sterilization Methods

Method

Regulatory Flags

DUNS number
689964302
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
08809283890009ORLUS MINI SCREW1H141061H141062015-12-16
08809283890023ORLUS MINI SCREW1H141071H141072015-12-16
08809283890047ORLUS MINI SCREW1H161051H161052015-12-16
08809283890061ORLUS MINI SCREW1H161061H161062015-12-16
08809283890085ORLUS MINI SCREW1H161071H161072015-12-16
08809283890108ORLUS MINI SCREW1H161081H161082015-12-16
08809283890122ORLUS MINI SCREW1H161091H161092015-12-16
08809283890146ORLUS MINI SCREW1H161101H161102015-12-16
08809283890160ORLUS MINI SCREW1H161111H161112015-12-16
08809283890184ORLUS MINI SCREW1H161121H161122015-12-16
08809283890207ORLUS MINI SCREW1H161131H161132015-12-16
08809283890221ORLUS MINI SCREW1H162061H162062015-12-16
08809283890245ORLUS MINI SCREW1H162071H162072015-12-16
08809283890269ORLUS MINI SCREW1H162081H162082015-12-16
08809283890283ORLUS MINI SCREW1H162091H162092015-12-16
08809283890306ORLUS MINI SCREW1H162101H162102015-12-16
08809283890320ORLUS MINI SCREW1H162111H162112015-12-16
08809283890344ORLUS MINI SCREW1H162121H162122015-12-16
08809283890368ORLUS MINI SCREW1H162131H162132015-12-16
08809283890382ORLUS MINI SCREW1H163081H163082015-12-16

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