FDA.reportPublic FDA data

DenBite

Primary DI
08717228440038
Brand
DenBite
Company
DuPhaMed B.V.
Model
DBU2011
Device description
X-Ray sensor holder Refill Pack Posterior Size 1, Content:5x posterior Upper Left / Lower Right - UDI 087172284415545x posterior Upper Right / Lower Left - UDI 08717228441561
Published
2023-11-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EGZHolder, Film, X-Ray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGZHolder, Film, X-RayDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08717228440038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717228440038087172284400388717228440038

GMDN Terms#

Term, Definition table
TermDefinition
Dental x-ray film holder, reusableA device designed to hold x-ray film while a dental x-ray is being taken and that enables insertion, positioning, stabilization, and removal of the x-ray film for either extraoral or intraoral dental imaging procedures. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
413491023
Device count
1
Premarket exempt
true
Combination product
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08717228440113DenBiteDBBBLS2023-11-24
08717228440120DenBiteDBU30012023-11-24
08717228440137DenBiteDBS012023-11-24
08717228440144DenBiteDBS022023-11-24
08717228440212DenBiteDBU34ES2023-11-24
08717228440366CeflaCEF4060979018602023-11-23
08717228440373CeflaCEF4061979018612023-11-23
08717228440380CeflaCEF4062979018622023-11-23
08717228440397CeflaCEF4063979018632023-11-23
08717228440403CeflaCEF4064966093472023-11-23
08717228440410CeflaCEFQRBBLS979014842023-11-23
08717228440427CeflaCEFS01979011132023-11-23
08717228440434CeflaCEFS02979011142023-11-23
08717228440458CeflaCEFFOAM979015572023-11-23
08717228440557Care Stream DentalBDA32BDA322023-11-23
08717228440564Care Stream DentalBDA33BDA332023-11-23
08717228440571Care Stream DentalIX014IX0142023-11-23
08717228440588Care Stream DentalIX015IX0152023-11-23
08717228440595Care Stream DentalIX016IX0162023-11-23
08717228442537Flow DentalEarflow34815002023-11-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456221891JMUJMU DENTAL, INCEGZ2026-06-08
00840456221907JMUJMU DENTAL, INCEGZ2026-06-08
00840456221914JMUJMU DENTAL, INCEGZ2026-06-08
00840456221921JMUJMU DENTAL, INCEGZ2026-06-08
00840456221938JMUJMU DENTAL, INCEGZ2026-06-08
00840456221945JMUJMU DENTAL, INCEGZ2026-06-08
00840456222317JMUJMU DENTAL, INCEGZ2026-06-08
00840456222324JMUJMU DENTAL, INCEGZ2026-06-08
00840456222331JMUJMU DENTAL, INCEGZ2026-06-08
00840456222348JMUJMU DENTAL, INCEGZ2026-06-08
00840456222355JMUJMU DENTAL, INCEGZ2026-06-08
00840456222362JMUJMU DENTAL, INCEGZ2026-06-08
00840456221884JMUJMU DENTAL, INCEGZ2026-06-05
10371347019633Advance Dental ProductsThe Atlanta Dental Supply CompanyEGZ2025-11-18
10304040192112CarinaHENRY SCHEIN, INC.EGZ2025-05-13
08717228440007DenBiteDuPhaMed B.V.EGZ2023-11-24
08717228440014DenBiteDuPhaMed B.V.EGZ2023-11-24
08717228440021DenBiteDuPhaMed B.V.EGZ2023-11-24
08717228440113DenBiteDuPhaMed B.V.EGZ2023-11-24
08717228440120DenBiteDuPhaMed B.V.EGZ2023-11-24
08717228440137DenBiteDuPhaMed B.V.EGZ2023-11-24
08717228440144DenBiteDuPhaMed B.V.EGZ2023-11-24
08717228440168DenBiteDuPhaMed B.V.EGZ2023-11-24
08717228440175DenBiteDuPhaMed B.V.EGZ2023-11-24
08717228440182DenBiteDuPhaMed B.V.EGZ2023-11-24
08717228440212DenBiteDuPhaMed B.V.EGZ2023-11-24
08717228440250CeflaDuPhaMed B.V.EGZ2023-11-23
08717228440281CeflaDuPhaMed B.V.EGZ2023-11-23
08717228440298CeflaDuPhaMed B.V.EGZ2023-11-23
08717228440366CeflaDuPhaMed B.V.EGZ2023-11-23