FDA.reportPublic FDA data

ASTRA TECH Implant System® EV

Primary DI
07392532180972
Brand
ASTRA TECH Implant System® EV
Company
Dentsply Implants Manufacturing GmbH
Model
25914
Catalog number
25914
Device description
HealDesign™ EV 4.8 Ø5.0-4.5mm
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZEIMPLANT, ENDOSSEOUS, ROOT-FORM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07392532180972PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07392532180972073925321809727392532180972

GMDN Terms#

Term, Definition table
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#

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
344038836
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07392532218965ANKYLOS®31033623310336232022-07-14
07392532220456ANKYLOS®31037500310375002022-07-14
07392532230011XiVE®45-601045-60102022-07-14
07392532230028XiVE®45-602045-60202022-07-14
07392532220166ANKYLOS®31037206310372062022-07-14
07392532218590ANKYLOS®31033370310333702025-10-17
07392532171673Astra Tech Implant System®25855258552022-11-11
07392532233661FRIOS®90-503790-50372022-07-15
07392532233678FRIOS®90-503890-50382022-07-15
07392532233920FRIADENT®91-451091-45102022-07-15
07392532066993Astra Tech Implant System®24573245732022-07-14
07392532072963Astra Tech Implant System®24801248012022-07-14
07392532151644Astra Tech Implant System®25721257212022-07-14
07392532151651Astra Tech Implant System®25722257222022-07-14
07392532151668Astra Tech Implant System®25723257232022-07-14
07392532151675Astra Tech Implant System®25769257692022-07-14
07392532169366Astra Tech Implant System®26098260982022-07-14
07392532169373Astra Tech Implant System®26099260992022-07-14
07392532218200ANKYLOS®31033030310330302022-07-14
07392532218224ANKYLOS®31033040310330402022-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290112780010Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112780522Dynamix Hex (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112780645Dynamix Hex (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112780652Dynamix Hex (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781215Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781222Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781246Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781260Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781284Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781710Dynamix Hex (Premium)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781727Dynamix Hex (Premium)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290114710565AbutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
08800070203415ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070203422ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070203439ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070203446ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070230367ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070230374ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070230381ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070230398ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229125ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229132ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229149ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229156ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229163ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229170ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229187ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229194ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229200ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229217ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26