FDA.reportPublic FDA data

LEONE SPA

Primary DI
08033707069300
Brand
LEONE SPA
Company
LEONE SPA
Model
P1602-00
Catalog number
P1602-00
Device description
BRACKET POSITIONING GAUGE 3-3,5mm RED
Published
2020-05-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
ECQAligner, Bracket, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECQAligner, Bracket, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08033707069300PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033707069300080337070693008033707069300

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic pliersA hand-held manual dental instrument designed to hold small objects or to bend or to cut metal strips or wire used in orthodontic procedures. It is typically made of high-grade steel and consists of two arms/rods that form a handle proximally and extend distally through a pivot point to terminate with jaws available in various shapes depending on intended use. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
432167294
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
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
G859PT20260010Clear Moves AlignerCLEAR MOVES ALIGNERSECQ2026-05-22
G149TBSB1240TBS BASICSACME ENTERPRISE.ECQ2026-05-20
G149TBSB1250TBS BASICSACME ENTERPRISE.ECQ2026-05-20
D175H3DMTA91MemoryTech AlignersHype Align Clear Orthodontics LimitadaECQ2026-02-10
D90970000913ORTHO ARCHOrtho Arch Company IncECQ2025-08-28
D9097000111ORTHO ARCHOrtho Arch Company IncECQ2025-08-28
D9097001011ORTHO ARCHOrtho Arch Company IncECQ2025-08-28
D9097001021ORTHO ARCHOrtho Arch Company IncECQ2025-08-28
D90970010M1ORTHO ARCHOrtho Arch Company IncECQ2025-08-28
D9097001111ORTHO ARCHOrtho Arch Company IncECQ2025-08-28
D90970011511ORTHO ARCHOrtho Arch Company IncECQ2025-08-28
D90970011713ORTHO ARCHOrtho Arch Company IncECQ2025-08-28
D909700117L1ORTHO ARCHOrtho Arch Company IncECQ2025-08-28
D90970011814ORTHO ARCHOrtho Arch Company IncECQ2025-08-28
D90970011915ORTHO ARCHOrtho Arch Company IncECQ2025-08-28
D909700119S1ORTHO ARCHOrtho Arch Company IncECQ2025-08-28
D90970012310ORTHO ARCHOrtho Arch Company IncECQ2025-08-28
D90970013210ORTHO ARCHOrtho Arch Company IncECQ2025-08-28
00371347018332Advance Dental ProductsThe Atlanta Dental Supply CompanyECQ2025-01-02
00371347018349Advance Dental ProductsThe Atlanta Dental Supply CompanyECQ2025-01-02
00723896026847SMILEGOODS ALIGNER CHEWIES MINT 24 PACKPRACTICON, INC.ECQ2024-08-07
00723896026854SMILEGOODS ALIGNER CHEWIES UNSCENTED 24 PACKPRACTICON, INC.ECQ2024-08-07
00723896026878SMILEGOODS ALIGNER CHEWIES MINT PRACTICON, INC.ECQ2024-08-07
00723896026885SMILEGOODS ALIGNER CHEWIES UNSCENTED PRACTICON, INC.ECQ2024-08-07
00723896026892SMILEGOODS ALIGNER CHEWIES ASSORTED 24 PACKPRACTICON, INC.ECQ2024-08-07
00723896026908SMILEGOODS ALIGNER CHEWIES ASSORTED PRACTICON, INC.ECQ2024-08-07
D90946300111ECLIPSE PASSIVE Ortho Arch Company IncECQ2023-06-20
D90946161116ECLIPSE INTERACTIVEOrtho Arch Company IncECQ2023-06-14
D909270106103LINGUAL BUTTON Ortho Arch Company IncECQ2023-06-13
D90927010613WELDABLE LINGUAL BUTTONSOrtho Arch Company IncECQ2023-06-13