FDA.reportPublic FDA data

Astra Tech Implant System®

Primary DI
07392532169366
Brand
Astra Tech Implant System®
Company
Dentsply Implants Manufacturing GmbH
Model
26098
Catalog number
26098
Device description
Overlay, Proline
Published
2022-07-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NDPAccessories, implant, dental, endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07392532189739Direct MarkingGS10
07392532169366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07392532189739073925321897397392532189739
07392532169366073925321693667392532169366

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument/implant rackA device designed as a small case, typically with a hinged lid that can be closed to protect the contents (i.e., surgical instruments and/or implantable devices such as plates or screws), and an integral rest(s) with grooves or notches in the upper edge so that the contents can be securely placed, protected, and organized. The lid or rest may be set at an angle to facilitate instrument/implant access during surgical procedures or sterilization. The device is typically be made of stainless steel or a suitable plastic material so that it can be sterilized. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
344038836
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
07392532169373Astra Tech Implant System®26099260992022-07-14
07392532218200ANKYLOS®31033030310330302022-07-14
07392532218224ANKYLOS®31033040310330402022-07-14
07392532218309ANKYLOS®31033095310330952022-07-14
07392532218606ANKYLOS®31033400310334002022-07-14
07392532219184ANKYLOS®31034350310343502022-07-14
07392532219191ANKYLOS®31034352310343522022-07-14
07392532219238ANKYLOS®31034372310343722022-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842092187722PreatPreat CorporationNDP2026-06-08
08056591028154JDentalCare Dental InstrumentsJ DENTAL CARE SRLNDP2026-06-08
00840481133756LOCATORZest Anchors, LLCNDP2026-06-05
07630031778086NAInstitut Straumann AGNDP2026-06-03
07630031778093NAInstitut Straumann AGNDP2026-06-03
07630031778109NAInstitut Straumann AGNDP2026-06-03
07630031778116NAInstitut Straumann AGNDP2026-06-03
07630031778123NAInstitut Straumann AGNDP2026-06-03
07630031778130NAInstitut Straumann AGNDP2026-06-03
07630031778147NAInstitut Straumann AGNDP2026-06-03
07630031778154NAInstitut Straumann AGNDP2026-06-03
07630031778161NAInstitut Straumann AGNDP2026-06-03
07630031778192NAInstitut Straumann AGNDP2026-06-03
07630031778208NAInstitut Straumann AGNDP2026-06-03
07630031778215NAInstitut Straumann AGNDP2026-06-03
07630031778222NAInstitut Straumann AGNDP2026-06-03
07630031778239NAInstitut Straumann AGNDP2026-06-03
07630031778260NAInstitut Straumann AGNDP2026-06-03
07630031778277NAInstitut Straumann AGNDP2026-06-03
07630031778284NAInstitut Straumann AGNDP2026-06-03
07630031778291NAInstitut Straumann AGNDP2026-06-03
07630031778307NAInstitut Straumann AGNDP2026-06-03
07630031778338NAInstitut Straumann AGNDP2026-06-03
07630031778345NAInstitut Straumann AGNDP2026-06-03
07630031778352NAInstitut Straumann AGNDP2026-06-03
07630031778369NAInstitut Straumann AGNDP2026-06-03
07630031778376NAInstitut Straumann AGNDP2026-06-03
07630031778406NAInstitut Straumann AGNDP2026-06-03
07630031778413NAInstitut Straumann AGNDP2026-06-03
07630031778420NAInstitut Straumann AGNDP2026-06-03