FDA.reportPublic FDA data

Cefla

Primary DI
08717228441042
Brand
Cefla
Company
DuPhaMed B.V.
Model
CEF2002
Catalog number
97901105
Device description
X-Ray sensor holder Refill Pack Bitewing Size 2
Published
2023-11-23
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
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
08717228440021PrimaryGS10
08717228440298PrimaryGS10
08717228441042Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717228440021087172284400218717228440021
08717228440298087172284402988717228440298
08717228441042087172284410428717228441042

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
10
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
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
17310234131044TrollByteDirecta ABEGZ2026-09-21
D090101399140DEXIS IXS Size 2 Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
D090101399150DEXIS IXS Size 2 Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
D090101399160DEXIS IXS Size 2 Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
D090101399170DEXIS IXS Size 1 Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
D090101399180DEXIS IXS Size 1 Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
D090101399190DEXIS IXS Size 1 Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
D090101461070DEXIS IXS Size 1 Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
D090101461090DEXIS IXS Size 2 Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
D090101461480DEXIS Titanium Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
D090101461490DEXIS Titanium Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
D090101461500DEXIS Titanium Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
D090101461510DEXIS Titanium Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
D090101461520DEXIS Titanium Accessory LayerDental Imaging Technologies CorporationEGZ2026-08-03
00856145008926Two ClikrayONE Universal Holders WINE + Two G-Rings and RodsCLIKTECH LLCEGZ2026-07-17
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