FDA.reportPublic FDA data

MEMFIX

Primary DI
07630031718259
Brand
MEMFIX
Company
Institut Straumann AG
Model
Fixation Screws
Catalog number
042.703V5
Device description
Crosshead mini-screws D1.5mm, L14mm
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZLSCREW, FIXATION, INTRAOSSEOUS

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K955369000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K955369000MEMFIXThe Straumann Co.1996-01-23DZL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630031718259PrimaryGS10
07630031747143Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630031718259076300317182597630031718259
07630031747143076300317471437630031747143

GMDN Terms#

Term, Definition table
TermDefinition
Screw endosteal dental implant, one-pieceA sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a one-piece device composed of an anchorage portion (implant body) in the form of a threaded screw that is implanted into bone, and a retention portion (implant abutment) that protrudes through gingival tissues to support the prosthesis.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length14Millimeter
Outer Diameter1.5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)448-8168info.usa@straumann.com

Regulatory Flags#

DUNS number
483599259
Device count
5
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630031782298Straumann Modular CassetteStorage Systems / Cassettes041.8192026-05-07
07630031770936Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53442026-04-08
07630031770943Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53452026-04-08
07630031770950Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53462026-04-08
07630031770967Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53552026-04-08
07630031770974Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53562026-04-08
07630031770981Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53572026-04-08
07630031770998Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53582026-04-08
07630031771001Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53592026-04-08
07630031771018Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53602026-04-08
07630031771025Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53612026-04-08
07630031771032Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53622026-04-08
07630031771049Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53632026-04-08
07630031771056Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53642026-04-08
07630031771063Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53652026-04-08
07630031771070Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53662026-04-08
07630031771087Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53672026-04-08
07630031771094Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53682026-04-08
07630031771100Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53692026-04-08
07630031771117Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53702026-04-08

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Primary DI, Brand, Company table
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