Grey MTA Plus

GUDID 00857570006044

Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This cement is supplied as a powder and gel for mixing prior to use. Cement is radiopaque.

Avalon Biomed Inc.

Endodontic filling/sealing material
Primary Device ID00857570006044
NIH Device Record Key0e70311f-6352-4f5f-b18a-6d7e9aa2bb17
Commercial Distribution StatusIn Commercial Distribution
Brand NameGrey MTA Plus
Version Model NumberG600
Company DUNS969855647
Company NameAvalon Biomed 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 Dimensions

Weight6 Gram

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Moisture will reduce the shelf life of the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Moisture will reduce the shelf life of the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Moisture will reduce the shelf life of the powder
Special Storage Condition, SpecifyBetween 0 and 0 *Moisture will reduce the shelf life of the powder

Device Identifiers

Device Issuing AgencyDevice ID
GS100857570006044 [Primary]

FDA Product Code

KIFResin, Root Canal Filling

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-15

On-Brand Devices [Grey MTA Plus]

00857570006136Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This ce
00857570006129Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This ce
00857570006051Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This ce
00857570006044Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This ce
00857570006037Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This ce
00857570006020Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This ce
00857570006013Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This ce

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