AxioSil Putty

GUDID D161260020

Axiodent Inc.

Composite dental impression material
Primary Device IDD161260020
NIH Device Record Key295bd08a-5511-45e9-b95f-0762d719bac4
Commercial Distribution StatusIn Commercial Distribution
Brand NameAxioSil Putty
Version Model Number26002 300ml
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
HIBCCD161260020 [Primary]

FDA Product Code

ELWMaterial, Impression

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

On-Brand Devices [AxioSil Putty]

D16126002026002 300ml
D16126001026001 150ml

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