FDA.reportPublic FDA data

LEONE SPA

Primary DI
08033707001430
Brand
LEONE SPA
Company
LEONE SPA
Model
A1730-07
Catalog number
A1730-07
Device description
PALATAL WIRES FIRST CLASS
Published
2021-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
EHPClasp, Preformed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHPClasp, PreformedDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08033707001430PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033707001430080337070014308033707001430

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic retainerAn orthodontic appliance, bonded or removable, intended to be used on a single patient to maintain teeth in corrected positions during the period of functional adaptation following corrective treatment. This appliance, also referred to as a positioner, is also used to maintain the positions of the teeth and jaws gained by orthodontic procedures.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
432167294
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08033707104513LEONE SPAA5133-97A5133-972026-05-28
08033707104827LEONE SPAA5134-02A5134-022026-04-01
08033707104834LEONE SPAA5134-03A5134-032026-04-01
08033707104469LEONE SPAR7200-08R7200-082025-09-11
08033707104476LEONE SPAA5132-07A5132-072025-09-11
08033707104483LEONE SPAA5132-17A5132-172025-09-11
08033707104490LEONE SPAA5132-95A5132-952025-09-11
08033707104506LEONE SPAA5132-97A5132-972025-09-11
08033707104391LEONE SPAA0620D911A0620D9112025-06-19
08033707104407LEONE SPAA0620D913A0620D9132025-06-19
08033707104414LEONE SPAA1621-911DA1621-911D2025-06-19
08033707104421LEONE SPAA1621-913DA1621-913D2025-06-19
08033707104438LEONE SPAA0631D908A0631D9082025-06-19
08033707104445LEONE SPAA0631D910A0631D9102025-06-19
08033707104452LEONE SPAA0631D912A0631D9122025-06-19
08033707094944LEONE SPAA0620D08A0620D082020-05-08
08033707094951LEONE SPAA0620D09A0620D092020-05-08
08033707094968LEONE SPAA0620D11A0620D112020-05-08
08033707094975LEONE SPAA0620D13A0620D132020-05-08
08033707103165LEONE SPAA0631D08A0631D082025-04-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
J01810171J-ClaspScheu-Dental GmbHEHP2024-11-19
J01810172J-ClaspScheu-Dental GmbHEHP2024-11-19
J01810181J-ClaspScheu-Dental GmbHEHP2024-11-19
J01810182J-ClaspScheu-Dental GmbHEHP2024-11-19
J01810191J-ClaspScheu-Dental GmbHEHP2024-11-19
J01810192J-ClaspScheu-Dental GmbHEHP2024-11-19
J01810211J-Clasp oblique Scheu-Dental GmbHEHP2024-11-19
J01810212J-Clasp obliqueScheu-Dental GmbHEHP2024-11-19
J01810221J-Clasp obliqueScheu-Dental GmbHEHP2024-11-19
J01810222J-Clasp oblique Scheu-Dental GmbHEHP2024-11-19
J01810231JM-ClaspScheu-Dental GmbHEHP2024-11-19
J01810261T-ClaspScheu-Dental GmbHEHP2024-11-19
J01810271T-ClaspScheu-Dental GmbHEHP2024-11-19
J01810471J-ClaspScheu-Dental GmbHEHP2024-11-19
J01810481J-Clasp obliqueScheu-Dental GmbHEHP2024-11-19
J01820481SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820482SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820491SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820492SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820493SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820501SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820502SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820503SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820511SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820512SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820513SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820521SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820522SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820531SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820532SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19