FDA.reportPublic FDA data

DBSWIN 5.11.0

Primary DI
E247E72000
Brand
DBSWIN 5.11.0
Company
DÜRR DENTAL SE
Model
E7200
Published
2016-09-21
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
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161444000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161444000DBSWIN and VistaEasy Imaging SoftwareDuerr Dental AG2016-06-21LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E247E72000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose dental x-ray system application softwareAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a general-purpose dental x-ray system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some application software routines or groups of routines (packages) must be combined with specific hardware or firmware configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315563684
Device count
1
Manufacturing date on label
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
E24721301004160VistaPosition BitewingRWT01.2A12024-05-17
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
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
05420060351235TRUMATCHMaterialise NVLLZ2026-10-22
05420060351242TRUMATCHMaterialise NVLLZ2026-10-22
05420060351259TRUMATCHMaterialise NVLLZ2026-10-22
05420060351266TRUMATCHMaterialise NVLLZ2026-10-22
05420060351273TRUMATCHMaterialise NVLLZ2026-10-22
05420060351280TRUMATCHMaterialise NVLLZ2026-10-22
05420060351297TRUMATCHMaterialise NVLLZ2026-10-22
05420060351303TRUMATCHMaterialise NVLLZ2026-10-22
05420060351310TRUMATCHMaterialise NVLLZ2026-10-22
05420060351327TRUMATCHMaterialise NVLLZ2026-10-22
05420060351334TRUMATCHMaterialise NVLLZ2026-10-22
05420060351341TRUMATCHMaterialise NVLLZ2026-10-22
05420060351358TRUMATCHMaterialise NVLLZ2026-10-22
05420060351365TRUMATCHMaterialise NVLLZ2026-10-22
05420060351372TRUMATCHMaterialise NVLLZ2026-10-22
05420060351389TRUMATCHMaterialise NVLLZ2026-10-22
05420060351396TRUMATCHMaterialise NVLLZ2026-10-22
05420060351402TRUMATCHMaterialise NVLLZ2026-10-22
B621ICOBRAINCTP1X7Y0icobrain ctpicometrix NVLLZ2026-10-22
00850631008919Roentgen WorksBrit Systems, LLCLLZ2026-10-21
00850631008926Roentgen WorksBrit Systems, LLCLLZ2026-10-21
05420060351228TruMatch CMF Titanium 3D Printed SplintsMaterialise NVLLZ2026-10-20
TKRL0001F1540PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F1B80PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F34K0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F6000PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F7300PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F7940PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F7F80PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F9F00PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20