FDA.reportPublic FDA data

Anew Implant System

Primary DI
07350081495114
Brand
Anew Implant System
Company
Dentatus AB
Model
ST-24L
Device description
Dentatus Anew Implant, blister pack including 1 pc
Published
2015-08-20
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
07350081494735PackageGS12In Commercial Distribution
07350081494742PackageGS11In Commercial Distribution
07350081495114PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350081494735073500814947357350081494735
07350081494742073500814947427350081494742
07350081495114073500814951147350081495114

GMDN Terms#

Term, Definition table
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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+46854650900info@dentatus.se
+12124811010dentatus@dentatus.com

Regulatory Flags#

DUNS number
355803412
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350081492335SurtexRST-18RST-182025-01-30
07350081495596SurtexSST-18SST-182025-01-30
07350081495602SurtexTST-18TST-182025-01-30
07350081490515Lamineer TipsLTA-100/2LTA-100/22025-01-28
07350081490539Lamineer TipsLTA-15/2LTA-15/22025-01-28
07350081490553Lamineer TipsLTA-150/2LTA-150/22025-01-28
07350081490577Lamineer TipsLTA-30/2LTA-30/22025-01-28
07350081490591Lamineer TipsLTA-39/2LTA-39/22025-01-28
07350081490621Lamineer TipsLTA-50/2LTA-50/22025-01-28
07350081490645Lamineer TipsLTA-75/2LTA-75/22025-01-28
07350081490669Lamineer TipsLTA-C50/2LTA-C50/22025-01-28
07350081490683Lamineer TipsLTA-D100/2LTA-D100/22025-01-28
07350081490706Lamineer TipsLTA-D150/2LTA-D150/22025-01-28
07350081490720Lamineer TipsLTA-D30/2LTA-D30/22025-01-28
07350081490751Lamineer TipsLTA-D50/2LTA-D50/22025-01-28
07350081490775Lamineer TipsLTA-E50/2LTA-E50/22025-01-28
07350081490898Lamineer TipsLTA-S100/2LTA-S100/22025-01-28
07350081490911Lamineer TipsLTA-S15/2LTA-S15/22025-01-28
07350081490935Lamineer TipsLTA-S150/2LTA-S150/22025-01-28
07350081490959Lamineer TipsLTA-S30/2LTA-S30/22025-01-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800070229125ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229132ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229149ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229156ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229163ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229170ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229187ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229194ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229200ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229217ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229224ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229231ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229248ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229255ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229262ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229279ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229286ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229293ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229309ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229316ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229323ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229330ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070228951ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070228968ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070228975ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08809822767892AnyOne Internal FixtureMegagen Implant Co. LtdDZE2023-06-12
08809822767908AnyOne Internal FixtureMegagen Implant Co. LtdDZE2023-06-12
08809822767922AnyOne Internal FixtureMegagen Implant Co. LtdDZE2023-06-12
08809822767946AnyOne Internal FixtureMegagen Implant Co. LtdDZE2023-06-12
08809822767953AnyOne Internal FixtureMegagen Implant Co. LtdDZE2023-06-12