FDA.reportPublic FDA data

Titan Implant

Primary DI
17290111271424
Brand
Titan Implant
Company
A.B. DENTAL DEVICES LTD
Model
I55-3.3,13
Catalog number
I55-3.3,13
Device description
Conical Implant, 3.3 mm Diameter, 13 mm lengh
Published
2019-06-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
17290111271424PackageGS110In Commercial Distribution
07290111271427PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729011127142417290111271424
07290111271427072901112714277290111271427

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter3.3Millimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
534128491
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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

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Primary DI, Brand, Company table
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08806395269907ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269914ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269921ABBA-ST Strong Co., Ltd.DZE2026-05-22
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08806395269952ABBA-ST Strong Co., Ltd.DZE2026-05-22
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08806395270019ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395270026ABBA-ST Strong Co., Ltd.DZE2026-05-22
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08800362100095DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100101DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20