FDA.reportPublic FDA data

VistaPosition Bitewing

Primary DI
E24721301004160
Brand
VistaPosition Bitewing
Company
DÜRR DENTAL SE
Model
RWT01.2A1
Published
2024-05-17
Public version status
Update
Distribution status
Not 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
E247G37201PackageHIBCC1In Commercial Distribution
E247G38201PackageHIBCC1In Commercial Distribution
E24721301004160PrimaryHIBCC0

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

Regulatory Flags#

DUNS number
315563684
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E24721301003290VistaPosition AnteriorRWT01.1D121301003292026-03-13
E24721301003300VistaPosition PosteriorRWT01.4D121301003302026-03-13
E24721301003320VistaPosition EndoRWT01.3D121301003322026-03-13
E24721301003330VistaPosition BitewingRWT01.2D121301003332026-03-13
E24721301004130VistaPosition AnteriorRWT01.A121301004132024-05-17
E24721301004140VistaPosition PosteriorRWT01.4A121301004132024-05-17
E24721301004150VistaPosition EndoRWT01.3A121301004152024-05-17
E2472110100003A20VistaSoft2110100003Version 4.0.x2025-09-22
E247A7000580511HVE Air Protect XL Plus, gray (4 pcs)A7000580512021-11-02
E247A7000580611HVE Air Protect XL Plus, gray (1 pcs)A7000580612021-11-02
E247A7000590111HVE Air Protect XL, gray (20 pcs)A7000590112021-11-02
E247A7000590511HVE Air Protect XL, gray (5 pcs)A7000590512021-11-02
E247E7300VisionXE7300Version 4.0.x2019-12-05
E247E72000DBSWIN 5.11.0E72002016-09-21
E247E7200A0DBSWINE7200A2019-04-09
E247G36110Phosphor Storage Plate IDX S1G36112021-09-19
E247G36120Phosphor Storage Plate IDX S2G36122021-09-19
E247G36130Phosphor Storage Plate IDX S3G36132021-09-19
E247G36140Phosphor Storage Plate IDX S4G36142021-09-19
E247732480ScanX Barrier Envelope, 100 Pcs, Size 0100 Pcs, Size 073248-02023-02-27

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