FDA.report

LEONE SPA

Primary DI
08033707095705
Brand
LEONE SPA
Company
LEONE SPA
Model
F6319-34
Catalog number
F6319-34
Device description
DB BKT 34 DIAGONALROUND ROTH22 T-17 BH
Published
2020-12-18
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
EJFBracket, Metal, Orthodontic

Product Code Classifications

CodeDeviceSpecialtyClass
EJFBracket, Metal, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08033707095705PrimaryGS10

GMDN Terms

TermDefinition
Self-ligating orthodontic bracketA ceramic device intended to be bonded to a tooth to hold an orthodontic archwire used to apply pressure to the tooth in order to alter the position of the tooth. It has an integral fixation clip, typically made of a polymer with a metal hinge, to retain the archwire (self-ligating) within a metal insert slot. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Sterilization Methods

Method

Regulatory Flags

DUNS number
432167294
Device count
1
DM exempt
false
Premarket exempt
true
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
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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
08033707103165LEONE SPAA0631D08A0631D082025-04-23
08033707103172LEONE SPAA0631D10A0631D102025-04-23
08033707103189LEONE SPAA0631D12A0631D122025-04-23
08033707103196LEONE SPAA0632-08DA0632-08D2025-04-23
08033707103202LEONE SPAA0632-10DA0632-10D2025-04-23
08033707103219LEONE SPAA0632-12DA0632-12D2025-04-23
08033707103226LEONE SPAA0640-10DA0640-10D2025-04-23
08033707103233LEONE SPAA0640-14DA0640-14D2025-04-23

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Primary DIBrandCompanyProduct codePublished
00190746191602Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191619Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191626Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191633Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191640Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191657Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191664Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191671Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191688Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191695Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191701Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191718Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191725Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191732Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191749Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191756Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191763Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191770Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191787Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191794Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191800Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191817Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191824Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191831Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191848Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191855Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191862Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191879Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191886Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191893Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23