Prosthetic Silicone Materials

Primary DI
05060483012476
Brand
Prosthetic Silicone Materials
Company
TECHNOVENT LIMITED
Model
CoForm Hard Impression Material – 40g
Catalog number
M518
Device description
Cartridge based silicone materials for taking external impressions to aid the construction of prostheses.
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
05060483012476PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060483012476050604830124765060483012476

GMDN Terms#

Term, Definition table
TermDefinition
Silicone dental impression materialAn elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.

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 Coform impression materials are supplied non-sterile in duel dispensing cartridges 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
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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
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05060483012148Prosthetic Silicone MaterialsTECHNOVENT LIMITEDGBI2024-07-22
05060483012155Prosthetic Silicone MaterialsTECHNOVENT LIMITEDGBI2024-07-22
05060483012162Prosthetic Silicone MaterialsTECHNOVENT LIMITEDGBI2024-07-22
05060483012452Prosthetic Silicone MaterialsTECHNOVENT LIMITEDGBI2024-07-22
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05060483013015Prosthetic Silicone MaterialsTECHNOVENT LIMITEDGBI2024-07-22
05060483013022Prosthetic Silicone MaterialsTECHNOVENT LIMITEDGBI2024-07-22
05060483013046Prosthetic Silicone MaterialsTECHNOVENT LIMITEDGBI2024-07-22
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