FDA.reportPublic FDA data

Titan Implants

Primary DI
07290107271202
Brand
Titan Implants
Company
A.B. DENTAL DEVICES LTD
Model
I10-4.2,11.5
Catalog number
I10-4.2,11.5
Device description
Trapeze Implant
Published
2024-09-11
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
K112440000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112440000AB DENTAL DEVICES IMPLANTS AND ACCESSORIESA.B. Dental Devices , Ltd.2012-04-18DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290107271202PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290107271202072901072712027290107271202

GMDN Terms#

Term, Definition table
TermDefinition
Screw endosteal dental implant, two-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 two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, 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
07290107270052Titan ImplantsI2-3.75,8I2-3.75,82024-11-19
07290107270106Titan ImplantsI2-4.2,8I2-4.2,82024-11-19
07290107270151Titan ImplantsI2-4.2,18I2-4.2,182024-11-19
07290107270274Titan ImplantsI2-6,8I2-6,82024-11-19
07290107270281Titan ImplantsI2-6,10I2-6,102024-11-19
07290107270298Titan ImplantsI2-6,11.5I2-6,11.52024-11-19
07290107270502Titan ImplantsI5-4.5,6I5-4.5,62024-11-19
07290107270564Titan ImplantsI5-5,6I5-5,62024-11-19
07290107270625Titan ImplantsI5-6,6I5-6,62024-11-19
07290107270793Titan ImplantsI6-2.4,13I6-2.4,132024-11-19
07290107270823Titan ImplantsI6-3,10I6-3,102024-11-19
07290107270830Titan ImplantsI6-3,11.5I6-3,11.52024-11-19
07290107270847Titan ImplantsI6-3,16I6-3,162024-11-19
07290107270854Titan ImplantsI6-3,13I6-3,132024-11-19
07290107270878Titan ImplantsI6-3.2,11.5I6-3.2,11.52024-11-19
07290107270885Titan ImplantsI6-3.2,13I6-3.2,132024-11-19
07290107270908Titan ImplantsI6b-2.4,11.5I6b-2.4,11.52024-11-19
07290107270915Titan ImplantsI6b-2.4,13I6b-2.4,132024-11-19
07290107271189Titan ImplantsI10-4.2,8I10-4.2,82024-11-19
07290107271226Titan ImplantsI10-4.2,16I10-4.2,162024-11-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800070203156ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203217ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203224ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203231ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203248ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203255ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203262ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203279ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203286ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203293ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203309ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203316ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203323ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203330ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203347ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203354ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203361ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203378ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203385ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203392ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203408ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800075200051I DoOneday Biotech Co.,Ltd.DZE2026-06-04
08800075200068I DoOneday Biotech Co.,Ltd.DZE2026-06-04
08800075200075I DoOneday Biotech Co.,Ltd.DZE2026-06-04
08800075200082I DoOneday Biotech Co.,Ltd.DZE2026-06-04
08800075200099I DoOneday Biotech Co.,Ltd.DZE2026-06-04
08800075200105I DoOneday Biotech Co.,Ltd.DZE2026-06-04
08800075200112I DoOneday Biotech Co.,Ltd.DZE2026-06-04
08800075200129I DoOneday Biotech Co.,Ltd.DZE2026-06-04
08800075200136I DoOneday Biotech Co.,Ltd.DZE2026-06-04