FDA.report

ASTRA TECH Implant System®

Primary DI
07392532002984
Brand
ASTRA TECH Implant System®
Company
Dentsply Implants Manufacturing GmbH
Model
22828
Catalog number
22828
Device description
Cast-to Abutment 4.0 NI
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
false
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
07392532002984PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07392532002984073925320029847392532002984

GMDN Terms

TermDefinition
Transgingival implantA sterile device intended to be surgically implanted through the oral mucosa and gingiva to provide support and a means of retention for a dental prosthesis.

Storage And Handling

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

Sterilization Methods

Method
Moist Heat or Steam Sterilization

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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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