CeraSeal Disposable Tips(10ea)

GUDID 08806387860037

CeraSeal is used for root canal filling after the removal of infected pulp tissue in the root canal. CeraSeal is in the form of a flowable paste and can be immediately applied inside the root canal using a disposable tip. material, and a thickening agent. This product characteristically cures slowly by absorbing the ambient water inside the root canal. It is white and aesthetic.

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 filling/sealing material
Primary Device ID08806387860037
NIH Device Record Key1e7ee980-172d-4473-80dd-0070f471d719
Commercial Distribution StatusIn Commercial Distribution
Brand NameCeraSeal Disposable Tips(10ea)
Version Model Number6003
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108806387860037 [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 Date2021-05-04
Device Publish Date2021-04-26

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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