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

• 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

Devices Manufactured by Meta Biomed Co., Ltd.

• 08806387860129 - EZ Bond Universal (EZB50): 2024-06-13 EZ Bond Universal is dentin adhesion system that functions as a conditioner, primer and adhesive resin in a single component. EZ
• 08806387860105 - CeraPutty CP10: 2023-11-23 CeraPutty (Bioceramic Root Repair Material) is a ready-to-use, premixed bioceramic root repair material developed for permanent
• 08806387860112 - CeraPutty CP05: 2023-11-23 CeraPutty (Bioceramic Root Repair Material) is a ready-to-use, premixed bioceramic root repair material developed for permanent
• 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): 2023-04-13 Metapex is a paste type root canal filling material. It is consist of Calcium Hydroxide with lodoform. 1 Syringe(2.2g)