Metapex Plus 0.8

GUDID 08806387894803

This product is a calcium hydroxide paste material that is temporarily filled into the root canal. It is pre-mixed in a syringe for convenient delivery in the root canal. When applied to root canal, it is alkaline by calcium hydroxide.The state of the treatment can be confirmed by the radiopacity of iodoform contained.Metapex Plus is used for patients of all ages requiring root canal treatment.

Meta Biomed Co., Ltd.

Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic temporary cement Endodontic temporary cement Endodontic temporary cement Endodontic temporary cement Endodontic temporary cement Endodontic temporary cement Endodontic temporary cement Endodontic temporary cement Endodontic temporary cement Endodontic temporary cement Endodontic temporary cement Endodontic temporary cement Endodontic temporary cement Endodontic temporary cement Endodontic temporary cement Endodontic temporary cement Endodontic temporary cement Endodontic temporary cement
Primary Device ID08806387894803
NIH Device Record Keyc172930e-bdbc-4be9-8d70-668fa2ab8a98
Commercial Distribution StatusIn Commercial Distribution
Brand NameMetapex Plus 0.8
Version Model Number9480
Company DUNS688322841
Company NameMeta Biomed Co., Ltd.
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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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
GS108806387894803 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KIFResin, Root Canal Filling

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-26
Device Publish Date2021-04-16

Devices Manufactured by Meta Biomed Co., Ltd.

08806387860105 - CeraPutty CP102023-11-23 CeraPutty (Bioceramic Root Repair Material) is a ready-to-use, premixed bioceramic root repair material developed for permanent
08806387860112 - CeraPutty CP052023-11-23 CeraPutty (Bioceramic Root Repair Material) is a ready-to-use, premixed bioceramic root repair material developed for permanent
08806387894780 - ADSEAL Plus Auto-Mix2023-06-19 ADSEAL Plus root canal sealer is a two component paste:paste device based upon epoxy-amine resin chemistry. This sealer is easy
08806387894773 - ADSEAL Plus2023-05-02 ADSEAL Plus root canal sealer is a two component paste:paste device based upon epoxy-amine resin chemistry. This sealer is easy
08806387860082 - EZ Bond Universal 5.0 (EZB50)2023-04-20 EZ Bond Universal is dentin adhesion system that functions as a conditioner, primer and adhesive resin in a single component.
08806387892069 - ADSEAL2023-04-19 Adseal root canal sealer is a two component paste:paste device based upon epoxy-amine resin chemistry. This sealer is easy to mi
08806387892007 - Metapex(1 Syringe)2023-04-13 Metapex is a paste type root canal filling material. It is consist of Calcium Hydroxide with lodoform. 1 Syringe(2.2g)
08806387892014 - Metapex(2 Syringe)2023-04-13 Metapex is a paste type root canal filling material. It is consist of Calcium Hydroxide with lodoform. 2 Syringe(2.2g)

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