Prosthetic Silicone Materials

Primary DI
05060483012131
Brand
Prosthetic Silicone Materials
Company
TECHNOVENT LIMITED
Model
Softening Agent – 100g
Catalog number
M513(100)
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.
Published
2024-07-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GBIMaterial, External Aesthetic Restoration, Used With Adhesive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBIMaterial, External Aesthetic Restoration, Used With AdhesiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060483012131PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060483012131050604830121315060483012131

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, resinA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.
Special Storage Condition, Specify00The 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.
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
225835156
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060483010496MagnabutmentsB-MA1-S Mini Magnabutment (Branemark) – S-RangeB-MA1-S2024-10-14
05060483010502MagnabutmentsB-MA2-S Maxi Magnabutment (Branemark) – S-RangeB-MA2-S 2024-10-14
05060483010519MagnabutmentsE-MA1-S Mini Magnabutment (Cochlear Vistafix, histE-MA1-S2024-10-14
05060483010526MagnabutmentsE-MA2-S Maxi Magnabutment (Cochlear Vistafix, histE-MA2-S 2024-10-14
05060483010540MagnabutmentsS-MA2-S Maxi Magnabutment (Straumann ITI) – S-RangS-MA2-S2024-10-14
05060483010601MagnabutmentsP-MA1-5.0-S Mini Magnabutment (Medicon, 5.0mm) – SP-MA1-5.0-S2024-10-14
05060483010625MagnabutmentsP-MA2-1.6-S Maxi Magnabutment (Medicon, 1.6mm) – SP-MA2-1.6-S2024-10-14
05060483010632MagnabutmentsP-MA2-3.5-S Maxi Magnabutment (Medicon, 3.5mm) – SP-MA2-3.5-S2024-10-14
05060483010649MagnabutmentsP-MA2-5.0-S Maxi Magnabutment (Medicon, 5.0mm) – SP-MA2-5.0-S2024-10-14
05060483010656MagnabutmentsP-MA2-6.5-S Maxi Magnabutment (Medicon, 6.5mm) – SP-MA2-6.5-S2024-10-14
05060483010663MagnabutmentsIE-MA1-S Mini Magnabutment (Southern Implants) – SIE-MA1-S2024-10-14
05060483010670MagnabutmentsIE-MA2-S Maxi Magnabutment (Southern Implants) – SIE-MA2-S 2024-10-14
05060483010687MagnabutmentsIT-MA1-S Mini Magnabutment (Southern Implants) – SIT-MA1-S 2024-10-14
05060483010694MagnabutmentsIT-MA2-S Maxi Magnabutment (Southern Implants) – SIT-MA2-S2024-10-14
05060483010700MagnabutmentsHX-MA1-S Mini Magnabutment (Southern Implants) – SHX-MA1-S 2024-10-14
05060483010717MagnabutmentsHX-MA2-S Maxi Magnabutment (Southern Implants) – SHX-MA2-S2024-10-14
05060483010076Prosthetic AdhesivesProBond Adhesive 37mlG6092024-07-22
05060483010755‘MagnaCap’ Magnetic Retention SystemMini Magnacap Astra Uni Abutment S-Range AMC1-S 2024-07-22
05060483010762‘MagnaCap’ Magnetic Retention SystemMaxi Magnacap Astra Uni Abutment S-Range AMC2-S 2024-07-22
05060483010779‘MagnaCap’ Magnetic Retention SystemMini Magnacap - Lab AnalogueB-LAC1 2024-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060483012087Prosthetic Silicone MaterialsTECHNOVENT LIMITEDGBI2024-07-22
05060483012094Prosthetic Silicone MaterialsTECHNOVENT LIMITEDGBI2024-07-22
05060483012100Prosthetic Silicone MaterialsTECHNOVENT LIMITEDGBI2024-07-22
05060483012117Prosthetic Silicone MaterialsTECHNOVENT LIMITEDGBI2024-07-22
05060483012124Prosthetic Silicone MaterialsTECHNOVENT LIMITEDGBI2024-07-22
05060483012148Prosthetic Silicone MaterialsTECHNOVENT LIMITEDGBI2024-07-22
05060483012155Prosthetic Silicone MaterialsTECHNOVENT LIMITEDGBI2024-07-22
05060483012162Prosthetic Silicone MaterialsTECHNOVENT LIMITEDGBI2024-07-22
05060483012452Prosthetic Silicone MaterialsTECHNOVENT LIMITEDGBI2024-07-22
05060483012476Prosthetic Silicone MaterialsTECHNOVENT LIMITEDGBI2024-07-22
05060483012698Prosthetic Silicone MaterialsTECHNOVENT LIMITEDGBI2024-07-22
05060483012704Prosthetic Silicone MaterialsTECHNOVENT LIMITEDGBI2024-07-22
05060483012995Prosthetic Silicone MaterialsTECHNOVENT LIMITEDGBI2024-07-22
05060483013015Prosthetic Silicone MaterialsTECHNOVENT LIMITEDGBI2024-07-22
05060483013022Prosthetic Silicone MaterialsTECHNOVENT LIMITEDGBI2024-07-22
05060483013046Prosthetic Silicone MaterialsTECHNOVENT LIMITEDGBI2024-07-22
05060483013053Prosthetic Silicone MaterialsTECHNOVENT LIMITEDGBI2024-07-22
05060483013077Prosthetic Silicone MaterialsTECHNOVENT LIMITEDGBI2024-07-22
05060483013084Prosthetic Silicone MaterialsTECHNOVENT LIMITEDGBI2024-07-22
05060483013107Prosthetic Silicone MaterialsTECHNOVENT LIMITEDGBI2024-07-22
05060483013114Prosthetic Silicone MaterialsTECHNOVENT LIMITEDGBI2024-07-22
05060483013138Prosthetic Silicone MaterialsTECHNOVENT LIMITEDGBI2024-07-22
05060483016108Prosthetic Silicone MaterialsTECHNOVENT LIMITEDGBI2024-07-22
05060483016177Prosthetic Silicone MaterialsTECHNOVENT LIMITEDGBI2024-07-22
05060483016184Prosthetic Silicone MaterialsTECHNOVENT LIMITEDGBI2024-07-22
05060483016191Prosthetic Silicone MaterialsTECHNOVENT LIMITEDGBI2024-07-22
05060483016207Prosthetic Silicone MaterialsTECHNOVENT LIMITEDGBI2024-07-22
05060483016214Prosthetic Silicone MaterialsTECHNOVENT LIMITEDGBI2024-07-22
05060483016221Prosthetic Silicone MaterialsTECHNOVENT LIMITEDGBI2024-07-22
05060483016238Prosthetic Silicone MaterialsTECHNOVENT LIMITEDGBI2024-07-22