Metapex(1 Syringe)

GUDID 08806387892007

Metapex is a paste type root canal filling material. It is consist of Calcium Hydroxide with lodoform. 1 Syringe(2.2g)

Meta Biomed Co., Ltd.

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• Primary Device ID: 08806387892007
• NIH Device Record Key: 117b4f6e-c4b5-4047-866c-f9c5c439cc4a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Metapex(1 Syringe)
• Version Model Number: 9200
• Company DUNS: 688322841
• Company Name: Meta Biomed Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806387892007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032603

FDA Product Code

• KIF: Resin, Root Canal Filling

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-04-13
• Device Publish Date: 2016-09-19

Devices Manufactured by Meta Biomed Co., Ltd.

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• 08806387894780 - ADSEAL Plus Auto-Mix: 2023-06-19 ADSEAL Plus root canal sealer is a two component paste:paste device based upon epoxy-amine resin chemistry. This sealer is easy
• 08806387894773 - ADSEAL Plus: 2023-05-02 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 - ADSEAL: 2023-04-19 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): 2023-04-13Metapex is a paste type root canal filling material. It is consist of Calcium Hydroxide with lodoform. 1 Syringe(2.2g)
• 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)