FDA.reportPublic FDA data

Magnabutments

Primary DI
05060483010540
Brand
Magnabutments
Company
TECHNOVENT LIMITED
Model
S-MA2-S Maxi Magnabutment (Straumann ITI) – S-Rang
Catalog number
S-MA2-S
Device description
Technovent Magnabutments are a form of magnetisable keeper which screw directly into a third party implant as part of a magnetic attachment system for implant retained craniofacial prostheses.
Published
2024-10-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Single use
true

Product Codes#

Code, Name table
CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060483010540PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060483010540050604830105405060483010540

GMDN Terms#

Term, Definition table
TermDefinition
Magnetic dental precision attachmentA device with magnetic properties designed for fixation of a removable dental prosthesis.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00It is recommended that they be stored and transported in their original packaging, at ambient temperature (between 15 and 30 degrees Celsius) and out of direct sunlight.
Special Storage Condition, Specify00The Magnabutments are supplied non-sterile and individually packaged for single patient use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
Sterilization required before use
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
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
05060483010786‘MagnaCap’ Magnetic Retention SystemMaxi Magnacap - Lab AnalogueB-LAC2 2024-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800070203156ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203217ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203224ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203231ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203248ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203255ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203262ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203279ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203286ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203293ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203309ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203316ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203323ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203330ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203347ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203354ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203361ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203378ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203385ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203392ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203408ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800075200051I DoOneday Biotech Co.,Ltd.DZE2026-06-04
08800075200068I DoOneday Biotech Co.,Ltd.DZE2026-06-04
08800075200075I DoOneday Biotech Co.,Ltd.DZE2026-06-04
08800075200082I DoOneday Biotech Co.,Ltd.DZE2026-06-04
08800075200099I DoOneday Biotech Co.,Ltd.DZE2026-06-04
08800075200105I DoOneday Biotech Co.,Ltd.DZE2026-06-04
08800075200112I DoOneday Biotech Co.,Ltd.DZE2026-06-04
08800075200129I DoOneday Biotech Co.,Ltd.DZE2026-06-04
08800075200136I DoOneday Biotech Co.,Ltd.DZE2026-06-04