Calasept® 1230100

GUDID 17310230000054

Directa AB

Calcium hydroxide dental cement
Primary Device ID17310230000054
NIH Device Record Keyb9a127ee-2139-4bb3-9707-1a80ae82732b
Commercial Distribution StatusIn Commercial Distribution
Brand NameCalasept®
Version Model NumberCalasept
Catalog Number1230100
Company DUNS353954381
Company NameDirecta AB
Device Count4
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS117310230000054 [Primary]
GS117310230000733 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EJKLiner, Cavity, Calcium Hydroxide

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

On-Brand Devices [Calasept®]

17310230000078Calasept
17310230000054Calasept

Trademark Results [Calasept]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CALASEPT
CALASEPT
80996215 0996215 Dead/Cancelled
Scania Dental AB
0000-00-00
CALASEPT
CALASEPT
73776775 1627931 Live/Registered
SCANIA DENTAL AB
1989-01-26

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