FDA.report

LEONE SPA

Primary DI
08033707065913
Brand
LEONE SPA
Company
LEONE SPA
Model
K0950-00
Catalog number
K0950-00
Device description
INTRAORAL ELASTIC APPLICATOR
Published
2020-05-04
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
false

Related Records

Product Codes

CodeName
JEXPlier, Orthodontic

Product Code Classifications

CodeDeviceSpecialtyClass
JEXPlier, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08033707065913PrimaryGS10

GMDN Terms

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

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

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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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