FDA.reportPublic FDA data

LEONE SPA

Primary DI
08033707002116
Brand
LEONE SPA
Company
LEONE SPA
Model
C0410-12
Catalog number
C0410-12
Device description
CHROMIUM-COBALT WIRE 1,2mm
Published
2016-09-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EJSAlloy, Other Noble Metal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJSAlloy, Other Noble MetalDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08033707002116PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033707002116080337070021168033707002116

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic wireA thread or slender rod of metal (e.g., stainless steel, precious metal) incorporated into an orthodontic appliance, typically as part of an orthodontic appliance system. It is available in various dimensions and grades, and is used to exert pressure on teeth in order to alter their position. This is a single-patient device that is used for the duration of the treatment (single-use) before being discarded.

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
00842092172766CekaPreat CorporationEJS2023-12-21
00842092166611CekaPreat CorporationEJS2023-12-21
00842092112922CekaPreat CorporationEJS2023-11-02
00841549118289Platinum Foil 1 DWT STERNGOLD DENTAL LLCEJS2023-10-06
D772031325005000POZZI MALIBU SILVER SOLDERAMERICAN TOOTH INDUSTRIESEJS2023-08-30
D772ATI070290010JUSTI PAKTO PURE ALLOY AMERICAN TOOTH INDUSTRIESEJS2023-08-30
D772ATI070290020JUSTI PAKTO PURE ALLOYAMERICAN TOOTH INDUSTRIESEJS2023-08-30
D772ATI290001K0JUSTI PAKTO PURE ALLOY AMERICAN TOOTH INDUSTRIESEJS2023-08-30
D772ATI32500010POZZI MALIBU SILVER SOLDERAMERICAN TOOTH INDUSTRIESEJS2023-08-30
D772ATI32500050POZZI MALIBU SILVER SOLDERAMERICAN TOOTH INDUSTRIESEJS2023-08-30
00843471101346The Orthodontic StoreYoung Innovations, Inc.EJS2022-11-24
00843471101353The Orthodontic StoreYoung Innovations, Inc.EJS2022-11-24
10843471101343The Orthodontic StoreYoung Innovations, Inc.EJS2022-11-24
10843471101350The Orthodontic StoreYoung Innovations, Inc.EJS2022-11-24
06970469230253Aidite Firing PasteAidite (Qinhuangdao) Technology Co., Ltd.EJS2022-04-07
D818100025ARGEBOND 80ARGEN CORPORATION, THEEJS2022-03-14
D818100270ARGELITE 50ARGEN CORPORATION, THEEJS2022-03-14
D818100273ARGELITE 54+ARGEN CORPORATION, THEEJS2022-03-14
D818100275ARGELITE 54BARGEN CORPORATION, THEEJS2022-03-14
D818100278ARGELITE 55ARGEN CORPORATION, THEEJS2022-03-14
D818100280ARGELITE 58PARGEN CORPORATION, THEEJS2022-03-14
D818100286ARGELITE 60ARGEN CORPORATION, THEEJS2022-03-14
D818100291ARGELITE 61ARGEN CORPORATION, THEEJS2022-03-14
D818100296ARGELITE 75+6ARGEN CORPORATION, THEEJS2022-03-14
D818100305ARGELITE 76SF+ARGEN CORPORATION, THEEJS2022-03-14
D818100323ARGELITE PF+ARGEN CORPORATION, THEEJS2022-03-14
D818100540ARGELITE 80SF+ARGEN CORPORATION, THEEJS2022-03-14
D818101549ARGELITE 52+ARGEN CORPORATION, THEEJS2022-03-14
D818101555ARGELITE 49ARGEN CORPORATION, THEEJS2022-03-14
D818102525ARGISTAR 40ARGEN CORPORATION, THEEJS2022-03-14