FDA.reportPublic FDA data

Kling Kuver Dental -

Primary DI
G031300KKTL0
Brand
Kling Kuver Dental -
Company
Shielding International Inc.
Model
300KKTL
Device description
Kling Kuver Dental - Adult - 0.25mm TL Lite Ply (TL) Width 23.5" (59.7 cm) Length 28" (71.1cm)
Published
2023-08-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
KPYShield, Protective, Personnel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPYShield, Protective, PersonnelRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G031300KKTL0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiation shielding apronA full or half-length apron-like garment intended to shield portions of the body of an individual (i.e., a device operator, patient, or other attending person) from exposure to radiation during medical or dental procedures. Some include attached or detachable collars for neck and thyroid protection. The device typically consists of a fluid resistant outer covering surrounding a thin sheet of lead (Pb) or lead-equivalent material. Those used for neutron attenuation are composed of hydrogenous materials; those used in mixed beta-gamma radiation field may have layers of both hydrogenous and lead-equivalent materials. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
009647322
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G031WABRX2XFLF0Wrap Around Back Relief Apron - BRX BeltWABRX2XFLF2023-10-17
G031WABRX2XFLFL0Wrap Around Back Relief Apron - BRX BeltWABRX2XFLFL2023-10-17
G031WABRX2XFNL0Wrap Around Back Relief Apron - BRX BeltWABRX2XFNL2023-10-17
G031WABRX2XFNLL0Wrap Around Back Relief Apron - BRX BeltWABRX2XFNLL2023-10-17
G031WABRX2XFRL0Wrap Around Back Relief Apron - BRX BeltWABRX2XFRL2023-10-17
G031WABRX2XFRLL0Wrap Around Back Relief Apron - BRX BeltWABRX2XFRLL2023-10-17
G031WABRX2XFTL0Wrap Around Back Relief Apron - BRX BeltWABRX2XFTL2023-10-17
G031WABRX2XFTLL0Wrap Around Back Relief Apron - BRX BeltWABRX2XFTLL2023-10-17
G031WABRX2XMLF0Wrap Around Back Relief Apron - BRX BeltWABRX2XMLF2023-10-17
G031WABRX2XMLFL0Wrap Around Back Relief Apron - BRX BeltWABRX2XMLFL2023-10-17
G031WABRX2XMNL0Wrap Around Back Relief Apron - BRX BeltWABRX2XMNL2023-10-17
G031WABRX2XMNLL0Wrap Around Back Relief Apron - BRX BeltWABRX2XMNLL2023-10-17
G031WABRX2XMRL0Wrap Around Back Relief Apron - BRX BeltWABRX2XMRL2023-10-17
G031WABRX2XMRLL0Wrap Around Back Relief Apron - BRX BeltWABRX2XMRLL2023-10-17
G031WABRX2XMTL0Wrap Around Back Relief Apron - BRX BeltWABRX2XMTL2023-10-17
G031WABRX2XMTLL0Wrap Around Back Relief Apron - BRX BeltWABRX2XMTLL2023-10-17
G031WABRXMFLF0Wrap Around Back Relief Apron - BRX BeltWABRXMFLF2023-10-17
G031WABRXMFLFL0Wrap Around Back Relief Apron - BRX BeltWABRXMFLFL2023-10-17
G031WABRXMFNL0Wrap Around Back Relief Apron - BRX BeltWABRXMFNL2023-10-17
G031WABRXMFNLL0Wrap Around Back Relief Apron - BRX BeltWABRXMFNLL2023-10-17

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Primary DI, Brand, Company table
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00850061871411IMAGE DIAGNOSTICS, INCIMAGE DIAGNOSTICS, INC.KPY2026-01-30
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05055449412414KenexKENEX (ELECTRO-MEDICAL) LIMITEDKPY2026-01-20
05055449412407KenexKENEX (ELECTRO-MEDICAL) LIMITEDKPY2026-01-07
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