Prosthetic Silicone Materials M514(20)

GUDID 05060483012124

Silicone polymer-based additives designed to thicken uncured prosthetic silicones.

TECHNOVENT LIMITED

Dental appliance fabrication material, resin

• Primary Device ID: 05060483012124
• NIH Device Record Key: c103d3ac-3542-44da-8aa5-85ad30f57a49
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prosthetic Silicone Materials
• Version Model Number: AntiSlump Agent – 20g
• Catalog Number: M514(20)
• Company DUNS: 225835156
• Company Name: TECHNOVENT LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.
• Special Storage Condition, Specify: Between 0 and 0 *The Thixotropic/Anti-Slump agents are supplied in plastic dropper bottles and it is recommended that they are stored in their original containers. Store out of direct sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.
• Special Storage Condition, Specify: Between 0 and 0 *The Thixotropic/Anti-Slump agents are supplied in plastic dropper bottles and it is recommended that they are stored in their original containers. Store out of direct sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.
• Special Storage Condition, Specify: Between 0 and 0 *The Thixotropic/Anti-Slump agents are supplied in plastic dropper bottles and it is recommended that they are stored in their original containers. Store out of direct sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.
• Special Storage Condition, Specify: Between 0 and 0 *The Thixotropic/Anti-Slump agents are supplied in plastic dropper bottles and it is recommended that they are stored in their original containers. Store out of direct sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.
• Special Storage Condition, Specify: Between 0 and 0 *The Thixotropic/Anti-Slump agents are supplied in plastic dropper bottles and it is recommended that they are stored in their original containers. Store out of direct sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.
• Special Storage Condition, Specify: Between 0 and 0 *The Thixotropic/Anti-Slump agents are supplied in plastic dropper bottles and it is recommended that they are stored in their original containers. Store out of direct sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.
• Special Storage Condition, Specify: Between 0 and 0 *The Thixotropic/Anti-Slump agents are supplied in plastic dropper bottles and it is recommended that they are stored in their original containers. Store out of direct sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.
• Special Storage Condition, Specify: Between 0 and 0 *The Thixotropic/Anti-Slump agents are supplied in plastic dropper bottles and it is recommended that they are stored in their original containers. Store out of direct sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.
• Special Storage Condition, Specify: Between 0 and 0 *The Thixotropic/Anti-Slump agents are supplied in plastic dropper bottles and it is recommended that they are stored in their original containers. Store out of direct sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.
• Special Storage Condition, Specify: Between 0 and 0 *The Thixotropic/Anti-Slump agents are supplied in plastic dropper bottles and it is recommended that they are stored in their original containers. Store out of direct sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.
• Special Storage Condition, Specify: Between 0 and 0 *The Thixotropic/Anti-Slump agents are supplied in plastic dropper bottles and it is recommended that they are stored in their original containers. Store out of direct sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.
• Special Storage Condition, Specify: Between 0 and 0 *The Thixotropic/Anti-Slump agents are supplied in plastic dropper bottles and it is recommended that they are stored in their original containers. Store out of direct sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.
• Special Storage Condition, Specify: Between 0 and 0 *The Thixotropic/Anti-Slump agents are supplied in plastic dropper bottles and it is recommended that they are stored in their original containers. Store out of direct sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.
• Special Storage Condition, Specify: Between 0 and 0 *The Thixotropic/Anti-Slump agents are supplied in plastic dropper bottles and it is recommended that they are stored in their original containers. Store out of direct sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.
• Special Storage Condition, Specify: Between 0 and 0 *The Thixotropic/Anti-Slump agents are supplied in plastic dropper bottles and it is recommended that they are stored in their original containers. Store out of direct sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.
• Special Storage Condition, Specify: Between 0 and 0 *The Thixotropic/Anti-Slump agents are supplied in plastic dropper bottles and it is recommended that they are stored in their original containers. Store out of direct sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.
• Special Storage Condition, Specify: Between 0 and 0 *The Thixotropic/Anti-Slump agents are supplied in plastic dropper bottles and it is recommended that they are stored in their original containers. Store out of direct sunlight.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060483012124 [Primary]

FDA Product Code

• GBI: Material, External Aesthetic Restoration, Used With Adhesive

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: 2024-07-30
• Device Publish Date: 2024-07-22

On-Brand Devices [Prosthetic Silicone Materials]

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• 05060483016276: Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
• 05060483016269: Silicone polymer-based additives designed to thicken uncured prosthetic silicones.
• 05060483016252: Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
• 05060483016245: Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
• 05060483016238: Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
• 05060483016221: Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
• 05060483016214: Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
• 05060483016207: Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
• 05060483016191: Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
• 05060483016184: Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
• 05060483016177: Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
• 05060483016108: Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
• 05060483013138: Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
• 05060483013114: Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
• 05060483013107: Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
• 05060483013084: Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
• 05060483013077: Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
• 05060483013053: Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
• 05060483013046: Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
• 05060483013022: Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
• 05060483013015: Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
• 05060483012995: Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
• 05060483012704: Technovent Extrinsic Colours and Sealant are products to extrinsically colour and seal colours o
• 05060483012698: Technovent Extrinsic Colours and Sealant are products to extrinsically colour and seal colours o
• 05060483012476: Cartridge based silicone materials for taking external impressions to aid the construction of pr
• 05060483012452: Cartridge based silicone materials for taking external impressions to aid the construction of pr
• 05060483012162: Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
• 05060483012155: Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
• 05060483012148: Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
• 05060483012131: Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
• 05060483012124: Silicone polymer-based additives designed to thicken uncured prosthetic silicones.
• 05060483012117: Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
• 05060483012100: Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
• 05060483012094: Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
• 05060483012087: Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi