AxioCem Bioactive

GUDID D161240040

Axiodent Inc.

Glass ionomer dental cement
Primary Device IDD161240040
NIH Device Record Key6b22f901-beec-4631-b650-5e9d8a5b6179
Commercial Distribution StatusIn Commercial Distribution
Brand NameAxioCem Bioactive
Version Model Number24004
Company DUNS119330625
Company NameAxiodent Inc.
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 Usetrue
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
HIBCCD161240040 [Primary]

FDA Product Code

EMACement, Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-14
Device Publish Date2024-10-04

Devices Manufactured by Axiodent Inc.

D161230560 - AxioComp NT2024-11-20
D161230570 - AxioComp NT2024-11-20
D161230580 - AxioComp NT2024-11-20
D161230590 - AxioComp NT2024-11-20
D161230600 - AxioComp NT2024-11-20
D161230610 - AxioComp NT2024-11-20
D161230620 - AxioComp NT2024-11-20
D161230630 - AxioComp NT2024-11-20

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