ProVecta 3D Prime

GUDID E2472210200389

DÜRR DENTAL SE

Cone beam computed tomography system, head/neck
Primary Device IDE2472210200389
NIH Device Record Key7778b446-43b9-4d0a-919c-bb84565ea632
Commercial Distribution StatusIn Commercial Distribution
Brand NameProVecta 3D Prime
Version Model Number2210200389
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 Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE2472210200389 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OASX-Ray, Tomography, Computed, Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-02-15
Device Publish Date2019-01-15

On-Brand Devices [ProVecta 3D Prime]

E24722102003892210200389
E247A77610X-Ray System
E247A77500X-Ray System

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