FDA.report

ASTRA TECH Implant System®

Primary DI
07392532049255
Brand
ASTRA TECH Implant System®
Company
Dentsply Implants Manufacturing GmbH
Model
24103
Catalog number
24103
Device description
Healing Abutment 5.5 Long
Published
2015-10-16
Public version status
Update
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
DZEIMPLANT, ENDOSSEOUS, ROOT-FORM

Product Code Classifications

CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07392532049255PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07392532049255073925320492557392532049255

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.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Storage in the original packaging, in a dry place, at normal room temperature.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)531-3481implants-na-cs@dentsply.com

Regulatory Flags

DUNS number
344038836
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
true
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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