FDA.reportPublic FDA data

MCBio Supertack Tack 3mm - N.5

Primary DI
08056992093010
Brand
MCBio Supertack Tack 3mm - N.5
Company
MC BIO SRL
Model
9514010-5
Device description
The MC Bio Supertack tacks are used for the stabilization of absorbable and non-absorbable membranes during the bonetissue regeneration and bone repair in the maxillofacial or mandibular area.The MC Bio Supertack system is designed to stabilize barrier membranes onto cortical plate bone, this may be used inmaxillofacial or mandibular bone.General patient health, bone type and quality, and functional loads exerted should be considered and carefully evaluatedprior to use.
Published
2024-12-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DZLScrew, Fixation, Intraosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZLScrew, Fixation, IntraosseousDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08056992093010PrimaryGS10
08057639710949Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056992093010080569920930108056992093010
08057639710949080576397109498057639710949

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial bone tack, non-bioabsorbableA small, cylindrical shaft typically with a flat, rounded head at one end and tapered to a point at the other, that is driven into craniofacial bone (includes maxilla and/or mandible) to provide stabilization for fracture repair and reconstructive procedures (e.g., dental regeneration membrane fixation); it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., titanium alloy). The device may be used when rigid fixation with bone plates and screws is not required.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
338319497
Device count
5
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08057639710567Specialist Organizer95708882025-06-23
08057639710574Tip with Indexable Stop95705662025-06-23
08057639710598Offset Tip SP95708602025-06-23
08057639710604Long Tip SP95705672025-06-23
08057639710628GBR MODULAR SET95753102025-06-23
080576397106355 Scraper box95725102025-06-23
08057639711960G-Special box95708902025-06-23
08057639711977Modular Box95745722025-06-23
08057639711984MT Tack organizer95744502025-06-23
08057639711991GBR Academia box95709002025-06-23
08057639712004Asymmetric Scraper box95753002025-06-23
08057639712011Straight Scraper Box95752302025-06-23
080576397120287 Scraper box95750802025-06-23
08057639712035Supertack box95705902025-06-23
08057639712042MC BIO Tack organizer95705702025-06-23
08057639712059Tuff Tack Box95705962025-06-23
08057639712066Handle - Straight MDF388502025-06-23
08057639712073Handle - Straight - Ergal303322025-06-23
08057639712080Handle - Straight SP (TiN)305482025-06-23
08057639712097Handle - Asym. - Ergal380462025-06-23

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