FDA.report

Small Diameter Implant System

Primary DI
07630031728104
Brand
Small Diameter Implant System
Company
Institut Straumann AG
Model
Healing Components
Catalog number
024.0008S
Device description
SC Healing Abutment, conical, oval, H 3.5mm, Ti
Published
2019-04-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Product Code Classifications

CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07630031728104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07630031728104076300317281047630031728104

GMDN Terms

TermDefinition
Dental implant suprastructure, temporary, preformed, single-useA prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device.

Device Sizes

TypeValueUnit
Height3.5Millimeter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight

Sterilization Methods

Method

Contacts

PhoneEmail
+1(801)448-8168info.usa@straumann.com

Regulatory Flags

DUNS number
483599259
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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