Prosthetic Silicone Materials

Basic Information

• Brand Name: Prosthetic Silicone Materials
• Primary DI: 05060483012131
• Version / Model: Softening Agent – 100g
• Catalog Number: M513(100)
• 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: 6240bf6a-7617-4231-9b8e-0b9fba0784f5

Device Description

Silicone materials for manufacture of adhesive or implant retained external maxillofacial materials. The softening agent is an additive to reduce the hardness of cured M511 silicone rubber. The Gel Part B is an alternative cross-linker for M511 which creates a gel material, rather than a rubber.

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	05060483012131	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius
• 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.
• Type: Special Storage Condition, Specify
• Special Conditions: The Softening Agent and Gel Part B are supplied in plastic dropper bottles and it is recommended that they are stored in their original containers. Store out of direct sunlight.