FDA.reportPublic FDA data

OCCLUSAL 4C START-UP KIT

Primary DI
06430035872947
Brand
OCCLUSAL 4C START-UP KIT
Company
PaloDEx Group Oy
Model
900801-DEX
Device description
OCCLUSAL 4C START-UP KIT
Published
2024-02-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
IWZFilm, Radiographic
PEMDental Barriers And Sleeves

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWZFilm, RadiographicRadiology1
PEMDental Barriers And SleevesGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06430035872947PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06430035872947064300358729476430035872947

GMDN Terms#

Term, Definition table
TermDefinition
Digital imaging storage phosphor screenA photostimulatable device used in medical imaging applications that is exposed to radiation by a diagnostic imaging x-ray system to record a patient radiation pattern, and then transferred to a computed radiography scanner to produce a digital image of the latent image formed on the device. The device is transported and shielded from room light by a computed radiography cassette.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
459955188
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06430035874637Imaging Plates901256-PTU2024-02-22
06430035874644Imaging Plates901257-PTU2024-02-22
06430035874651Imaging Plates901258-PTU2024-02-22
06430035874668Imaging Plates901259-PTU2024-02-22
06430035874675Imaging Plates901248-PTU2024-02-22
06430035874682Imaging Plates901249-PTU2024-02-22
06430035874699Imaging Plates901250-PTU2024-02-22
06430035874705Imaging Plates901251-PTU2024-02-22
06430035874996Imaging Plates901244-PTU2024-02-22
06430035875009Imaging Plates901245-PTU2024-02-22
06430035875016Imaging Plates901246-PTU2024-02-22
06430035875023Imaging Plates901247-PTU2024-02-22
06430035875030Imaging Plates901252-PTU2024-02-22
06430035875047Imaging Plates901253-PTU2024-02-22
06430035875054Imaging Plates901254-PTU2024-02-22
06430035875061Imaging Plates901255-PTU2024-02-22
06430035873357COMFORT OCCLUSAL 4C ACCESSORY KIT900320-PTU900320-PTU2025-12-23
06430035873388OCCLUSAL 4C REFILL KIT900802-DEX2025-12-23
06430035875191ORTHOPANTOMOGRAPH™ OP 3DPCX-1901308-PTU2025-07-15
06430035875184ORTHOPANTOMOGRAPH™ OP 3DPCX-1901307-PTU2025-03-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810050855843Rad ControlTYPENEX MEDICAL LLCIWZ2026-05-06
10618125192301CarinaTIDI PRODUCTS, LLCPEM2025-09-22
20665973031815UnipackDukal LLCPEM2025-03-20
20665973031822UnipackDukal LLCPEM2025-03-20
20665973031839UnipackDukal LLCPEM2025-03-20
10304040186722AccleanHENRY SCHEIN, INC.PEM2024-10-02
20850061028024Dental BasicsDental Basics Inc.PEM2024-05-08
06430035874637Imaging PlatesPaloDEx Group OyIWZ2024-02-22
06430035874644Imaging PlatesPaloDEx Group OyIWZ2024-02-22
06430035874651Imaging PlatesPaloDEx Group OyIWZ2024-02-22
06430035874668Imaging PlatesPaloDEx Group OyIWZ2024-02-22
06430035874675Imaging PlatesPaloDEx Group OyIWZ2024-02-22
06430035874682Imaging PlatesPaloDEx Group OyIWZ2024-02-22
06430035874699Imaging PlatesPaloDEx Group OyIWZ2024-02-22
06430035874705Imaging PlatesPaloDEx Group OyIWZ2024-02-22
06430035874996Imaging PlatesPaloDEx Group OyIWZ2024-02-22
06430035875009Imaging PlatesPaloDEx Group OyIWZ2024-02-22
06430035875016Imaging PlatesPaloDEx Group OyIWZ2024-02-22
06430035875023Imaging PlatesPaloDEx Group OyIWZ2024-02-22
06430035875030Imaging PlatesPaloDEx Group OyIWZ2024-02-22
06430035875047Imaging PlatesPaloDEx Group OyIWZ2024-02-22
06430035875054Imaging PlatesPaloDEx Group OyIWZ2024-02-22
06430035875061Imaging PlatesPaloDEx Group OyIWZ2024-02-22
10371347011941Advance Dental ProductsThe Atlanta Dental Supply CompanyPEM2024-01-04
10371347011958Advance Dental ProductsThe Atlanta Dental Supply CompanyPEM2024-01-04
10665973029372UnipackDukal LLCPEM2022-12-06
30665973027211DukalDukal LLCPEM2022-12-06
30665973027228DukalDukal LLCPEM2022-12-06
10810063751927Safco SafeWrap Curing Light SleevesSAFCO DENTAL SUPPLY CO.PEM2022-12-02
10810063751965Safco SafeWrap Chair SleevesSAFCO DENTAL SUPPLY CO.PEM2022-12-02