FDA.reportPublic FDA data

LEONE SPA

Primary DI
08033707002925
Brand
LEONE SPA
Company
LEONE SPA
Model
C1231-00
Catalog number
C1231-00
Device description
COIL SPRINGS MEMORIA ENDS/LIG CLOSED L
Published
2020-05-19
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
ECOSpring, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECOSpring, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08033707002925PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033707002925080337070029258033707002925

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic springA dental device in the shape of a coil intended to be placed around an archwire, a rod, in a bracket, on hooks, pins, and/or between teeth, to apply force (e.g., rotational, uprighting, horizontal) as part of an orthodontic force-producing appliance system. 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
07895742274726MorelliDental Morelli LtdaECO2026-06-02
00190746203992Stainless Steel SpringAMERICAN ORTHODONTICS CORPORATIONECO2026-04-21
10371347023111Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2026-04-14
10371347023128Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2026-04-14
10371347023135Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2026-04-14
10371347023142Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2026-04-14
10371347023159Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2026-04-14
10371347023166Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2026-04-14
10371347023173Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2026-04-14
10371347023180Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2026-04-14
10371347023197Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2026-04-14
07908611215161ORTHODONTIC TORQUE SPRING 17X25 SMALL 10 UN ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECO2026-01-12
07908611215178ORTHODONTIC TORQUE SPRING 17X25 MEDIUM 10 UN ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECO2026-01-12
07908611215185ORTHODONTIC TORQUE SPRING 17X25 LARGE 10 UN ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECO2026-01-12
07908611215192ORTHODONTIC TORQUE SPRING 18X25 SMALL 10 UN ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECO2026-01-12
07908611215208ORTHODONTIC TORQUE SPRING 18X25 MEDIUM 10 UN ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECO2026-01-12
07908611215215ORTHODONTIC TORQUE SPRING 18X25 LARGE 10 UN ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECO2026-01-12
07908611215222ORTHODONTIC TORQUE SPRING 19X25 SMALL 10 UN ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECO2026-01-12
07908611215239ORTHODONTIC TORQUE SPRING 19X25 MEDIUM 10 UN ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECO2026-01-12
07908611215246ORTHODONTIC TORQUE SPRING 19X25 LARGE 10 UN ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECO2026-01-12
10371347019374Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2024-12-27
10371347019381Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2024-12-27
10371347019398Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2024-12-27
10371347019404Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2024-12-27
10371347019411Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2024-12-26
10371347019428Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2024-12-26
10371347014577Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2024-11-15
10371347014553Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2024-08-27
10371347014560Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2024-08-27
10371347014584Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2024-08-27