Prosthetic Silicone Materials Z004(500g)

GUDID 05060483012100

Silicone materials for manufacture of adhesive or implant retained external maxillofacial materials. The High Consistency Rubber (HCR) Prosthetic Silicones (1:1) are a range of 2 parts (A and B) silicone rubber materials for prosthetic use which are mixed 1:1 by weight ratio A:B.

TECHNOVENT LIMITED

Dental appliance fabrication material, resin

• Primary Device ID: 05060483012100
• NIH Device Record Key: 0f3c4715-9808-4f8a-9cbe-a1c7a66076e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prosthetic Silicone Materials
• Version Model Number: High Strength Silicone Rubber – 500g
• Catalog Number: Z004(500g)
• 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 Prosthetic Silicones (1:1 ratio) are supplied non-sterile in plastic or glass containers and it is recommended that they are stored in their original containers.
• 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 Prosthetic Silicones (1:1 ratio) are supplied non-sterile in plastic or glass containers and it is recommended that they are stored in their original containers.
• 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 Prosthetic Silicones (1:1 ratio) are supplied non-sterile in plastic or glass containers and it is recommended that they are stored in their original containers.
• 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 Prosthetic Silicones (1:1 ratio) are supplied non-sterile in plastic or glass containers and it is recommended that they are stored in their original containers.
• 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 Prosthetic Silicones (1:1 ratio) are supplied non-sterile in plastic or glass containers and it is recommended that they are stored in their original containers.
• 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 Prosthetic Silicones (1:1 ratio) are supplied non-sterile in plastic or glass containers and it is recommended that they are stored in their original containers.
• 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 Prosthetic Silicones (1:1 ratio) are supplied non-sterile in plastic or glass containers and it is recommended that they are stored in their original containers.
• 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 Prosthetic Silicones (1:1 ratio) are supplied non-sterile in plastic or glass containers and it is recommended that they are stored in their original containers.
• 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 Prosthetic Silicones (1:1 ratio) are supplied non-sterile in plastic or glass containers and it is recommended that they are stored in their original containers.
• 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 Prosthetic Silicones (1:1 ratio) are supplied non-sterile in plastic or glass containers and it is recommended that they are stored in their original containers.
• 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 Prosthetic Silicones (1:1 ratio) are supplied non-sterile in plastic or glass containers and it is recommended that they are stored in their original containers.
• 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 Prosthetic Silicones (1:1 ratio) are supplied non-sterile in plastic or glass containers and it is recommended that they are stored in their original containers.
• 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 Prosthetic Silicones (1:1 ratio) are supplied non-sterile in plastic or glass containers and it is recommended that they are stored in their original containers.
• 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 Prosthetic Silicones (1:1 ratio) are supplied non-sterile in plastic or glass containers and it is recommended that they are stored in their original containers.
• 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 Prosthetic Silicones (1:1 ratio) are supplied non-sterile in plastic or glass containers and it is recommended that they are stored in their original containers.
• 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 Prosthetic Silicones (1:1 ratio) are supplied non-sterile in plastic or glass containers and it is recommended that they are stored in their original containers.
• 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 Prosthetic Silicones (1:1 ratio) are supplied non-sterile in plastic or glass containers and it is recommended that they are stored in their original containers.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060483012100 [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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• 05060483016245: Silicone materials for manufacture of adhesive or implant retained external maxillofacial materi
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• 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
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• 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