FDA.reportPublic FDA data

Titan Implants

Primary DI
07290107270830
Brand
Titan Implants
Company
A.B. DENTAL DEVICES LTD
Model
I6-3,11.5
Catalog number
I6-3,11.5
Device description
Narrow Integral Implant
Published
2024-11-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132125000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132125000A.B. DENTAL DEVICES DENTAL IMPLANTS SYSTEMA.B. Dental Devices , Ltd.2014-01-21DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290107270830PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290107270830072901072708307290107270830

GMDN Terms#

Term, Definition table
TermDefinition
Screw endosteal dental implant, one-pieceA sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a one-piece device composed of an anchorage portion (implant body) in the form of a threaded screw that is implanted into bone, and a retention portion (implant abutment) that protrudes through gingival tissues to support the prosthesis.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+972732454900info@ab-dent.com

Regulatory Flags#

DUNS number
534128491
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290107273008Prosthetic AccessoriesP24-bT_NP24-bT_N2026-08-25
07290107273329Prosthetic AccessoriesP25aP25a2026-08-25
07290107273336Prosthetic AccessoriesP25b-10P25b-102026-08-25
07290107277921Prosthetic AccessoriesP4LN-3.75,25P4LN-3.75,252026-08-25
07290107278607Prosthetic AccessoriesP64-3.75,17-4P64-3.75,17-42026-08-25
07290107278614Prosthetic AccessoriesP64-3.75,17-5P64-3.75,17-52026-08-25
07290107278638Prosthetic AccessoriesP64-3.75,30-4P64-3.75,30-42026-08-25
07290107278645Prosthetic AccessoriesP64-3.75,30-5P64-3.75,30-52026-08-25
07290111273292Prosthetic AccessoriesP4C-4,15P4C-4,152026-08-25
07290111273308Prosthetic AccessoriesP4C-4,25P4C-4,252026-08-25
07290111273346Prosthetic AccessoriesP4LC-4,15P4LC-4,152026-08-25
07290111273353Prosthetic AccessoriesP4LC-4,25P4LC-4,252026-08-25
07290111275043Prosthetic AccessoriesP14C-bTP14C-bT2026-08-25
07290111275050Prosthetic AccessoriesP14C-bT-ARP14C-bT-AR2026-08-25
07290111275067Prosthetic AccessoriesP14C-bTs-ARP14C-bTs-AR2026-08-25
07290111275074Prosthetic AccessoriesP14C-bTs-CP14C-bTs-C2026-08-25
07290111275364Prosthetic AccessoriesP55C-4,1P55C-4,12026-08-25
07290111275371Prosthetic AccessoriesP55C-4,2P55C-4,22026-08-25
07290111275388Prosthetic AccessoriesP55C-4,3P55C-4,32026-08-25
07290111275395Prosthetic AccessoriesP55C-4,4P55C-4,42026-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07392532000430Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532000447Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532000874Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532000942Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532000959Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532002731Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532002748Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532037115Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532037122Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532049613Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532049620Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532049637Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532049644Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532049651Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532049668Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532062841Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532036965Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-10-17
07392532036972Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-10-17
07392532036989Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-10-17
07392532049576ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-31
07392532049583ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-31
07392532066047ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-31
07392532066054ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-31
07392532067778ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-31
07392532067785ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-31
07392532000928ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-16
07392532000935ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-16
07392532002649ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-16
07392532002656ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-16
07392532002663ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-16