Prosthetic Silicone Materials

Basic Information

• Brand Name: Prosthetic Silicone Materials
• Primary DI: 05060483012117
• Version / Model: High Strength Silicone Rubber – 1kg
• Catalog Number: Z004(1kg)
• Company Name: TECHNOVENT LIMITED
• Labeler DUNS: 225835156
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-22
• Public Version: 1
• Public Version Date: 2024-07-30
• Public Version Status: New
• Public Device Record Key: 7b703989-20bc-43e6-9c43-b101c4b27e09

Device Description

Silicone materials for manufacture of adhesive or implant retained external maxillofacial materials. The 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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GBI	Material, External Aesthetic Restoration, Used With Adhesive	General, Plastic Surgery	878.3800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16730	Dental appliance fabrication material, resin	A resin intended to be used in the dental laboratory to manufacture a patient-worn dental prosthesis or appliance (e.g., denture base, occlusal splint/night guard), that either: 1) polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured); or 2) can be shaped by a dental mill [e.g., based on computer-aided design/computer-aided manufacturing (CAD/CAM) technology]. It may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). After application, this material cannot be refabricated.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060483012117	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: 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.
• Type: Special Storage Condition, Specify
• Special Conditions: Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.