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
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.

08806387860037 - CeraSeal Disposable Tips(10ea)2021-05-04CeraSeal 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.
08806387860037 - CeraSeal Disposable Tips(10ea)2021-05-04 CeraSeal is used for root canal filling after the removal of infected pulp tissue in the root canal. CeraSeal is in the form of
08806387894797 - Metapex Plus 2.22021-04-26 This product is a calcium hydroxide paste material that is temporarily filled into the root canal. It is pre-mixed in a syringe
08806387894803 - Metapex Plus 0.82021-04-26 This product is a calcium hydroxide paste material that is temporarily filled into the root canal. It is pre-mixed in a syringe
08806387894827 - Metapex Plus 4.42021-04-26 This product is a calcium hydroxide paste material that is temporarily filled into the root canal. It is pre-mixed in a syringe
08806387894810 - CeraSeal 0.5-Pouch2020-04-14 CeraSeal is used for root canal filling after the removal of infected pulp tissue in the root canal. CeraSeal is in the form of
08806387894841 - CeraSeal 0.5-BOX2020-04-14 CeraSeal is used for root canal filling after the removal of infected pulp tissue in the root canal. CeraSeal is in the form of
08806387894100 - Meta P&Bond2020-04-13 Meta P&Bond is a wet bond adhesive system that is activated by visible light curing. This bonding agent is one-step for priming
08806387894834 - KometSeal2020-04-01 KometsSeal root canal sealer is a two component paste:paste device based upon epoxy-amine resin chemistry. This sealer is easy t

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