FDA.report

LEONE SPA

Primary DI
08033707069867
Brand
LEONE SPA
Company
LEONE SPA
Model
R3716-00
Catalog number
R3716-00
Device description
NATURAL PROTECTIVE WAX
Published
2020-05-06
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
EGDWax, Dental, Intraoral

Product Code Classifications

CodeDeviceSpecialtyClass
EGDWax, Dental, IntraoralDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08033707069867PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08033707069867080337070698678033707069867

GMDN Terms

TermDefinition
Orthodontic appliance relief materialA device used to cover the offending sharp edges of an orthodontic appliance being worn by the user in order to provide relief from the discomforts that this can cause. It can be presented as a sheet, strip, or rod and is typically made of a mouldable wax or silicone material that is easy to manipulate with the fingers in order to cover the offending protrusions of the orthodontic appliance that are causing irritations in the patient's mouth. This is a single-use 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

Other Devices From This Company

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08033707104483LEONE SPAA5132-17A5132-172025-09-11
08033707104490LEONE SPAA5132-95A5132-952025-09-11
08033707104506LEONE SPAA5132-97A5132-972025-09-11
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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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