FDA.report

11mm Mini Screw Button Type

Primary DI
D8199015010
Brand
11mm Mini Screw Button Type
Company
SPECIALTY APPLIANCES, LLC
Model
901501
Published
2024-11-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
OATImplant, Endosseous, Orthodontic

Product Code Classifications

CodeDeviceSpecialtyClass
OATImplant, Endosseous, OrthodonticDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D8199015010PrimaryHIBCC0

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.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
106645484
Device count
1
DM exempt
false
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

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D8199512460G4 NiTi Lingual Wire .010 Small Lower9512462025-07-18
D8199512470G4 NiTi Lingual Wire .010 Medium Upper9512472025-07-18
D8199512480G4 NiTi Lingual Wire .010 Medium Lower9512482025-07-18
D8199512490G4 NiTi Lingual Wire .010 Large Upper9512492025-07-18
D8199512500G4 NiTi Lingual Wire .010 Large Lower9512502025-07-18
D8199512510G4 NiTi Lingual Wire .013 Small Upper9512512025-07-18
D8199512520G4 NiTi Lingual Wire .013 Small Lower9512522025-07-18
D8199512530G4 NiTi Lingual Wire .013 Medium Upper9512532025-07-18
D8199512540G4 NiTi Lingual Wire .013 Medium Lower9512542025-07-18
D8199512550G4 NiTi Lingual Wire .013 Large Upper9512552025-07-18
D8199512560G4 NiTi Lingual Wire .013 Large Lower9512562025-07-18
D8199512570G4 NiTi Lingual Wire .016 Small Upper9512572025-07-18
D8199512580G4 NiTi Lingual Wire .016 Small Lower9512582025-07-18
D8199512590G4 NiTi Lingual Wire .016 Medium Upper9512592025-07-18
D8199512600G4 NiTi Lingual Wire .016 Medium Lower9512602025-07-18
D8199512610G4 NiTi Lingual Wire .016 Large Upper9512612025-07-18
D8199512620G4 NiTi Lingual Wire .016 Large Lower9512622025-07-18
D8199015462Printed Upper Crown Pack for Herbst UL59015462025-04-03
D8199015472Printed Upper Crown Pack for Herbst UL69015472025-04-03

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