DBSWIN 5.11.0

GUDID E247E72000

DÜRR DENTAL SE

General-purpose dental x-ray system application software
Primary Device IDE247E72000
NIH Device Record Key61dad85b-eb22-4206-a38a-becd0d71d9bb
Commercial Distribution StatusIn Commercial Distribution
Brand NameDBSWIN 5.11.0
Version Model NumberE7200
Company DUNS315563684
Company NameDÜRR DENTAL SE
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE247E72000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-16
Device Publish Date2016-09-21

Devices Manufactured by DÜRR DENTAL SE

E24721301004130 - VistaPosition Anterior2024-05-27
E24721301004140 - VistaPosition Posterior2024-05-27
E24721301004150 - VistaPosition Endo2024-05-27
E24721301004160 - VistaPosition Bitewing2024-05-27
E247G37101 - VistaPosition Anterior/ Posterior Kit Titanium2024-05-27
E247G38101 - VistaPosition Anterior/ Posterior Kit2024-05-27
E247732480 - ScanX Barrier Envelope, 100 Pcs, Size 02023-03-07 Light protection covers for image plates (used with the ScanX image plate scanners).
E247732482 - ScanX Barrier Envelope, 300 Pcs, Size 22023-03-07 Light protection covers for image plates (used with the ScanX image plate scanners).

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.