GuttaSil Refill

GUDID 08806387894117

GuttaSil, a product in the form of a paste which combines gutta-percha with a sealer. The gutta-percha powder is mixed in a matrix of polyvinylsiloxane. It is convenient since sealing and obturation are simultaneously possible without heating and the root canal can be filled in a quick manner. This device contains a syringe, auto-mix& Endo tips, spatula, and mixing pads.

Meta Biomed Co., Ltd.

Endodontic filling/sealing material Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement

• Primary Device ID: 08806387894117
• NIH Device Record Key: 9d6f0d62-cebb-448a-8d46-f914419b31f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GuttaSil Refill
• Version Model Number: 9411
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806387894117 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190510

FDA Product Code

• EKM: Gutta-Percha

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-02
• Device Publish Date: 2019-06-24

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