FDA.reportPublic FDA data

Implant-One

Primary DI
D762IW34514000
Brand
Implant-One
Company
Implant Logistics, Inc.
Model
IW3-4514-00
Device description
300 Series Wide Thread, Root Form Implant, 4.5mm Diameter x 14mm Length. Included with the implant is the matching, sterile packed, carrier and cover screw.
Published
2020-08-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
D762IW34514000PrimaryHIBCC0

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
1-844-383-8001CustomerService@implantlogistics.com

Regulatory Flags#

DUNS number
079280537
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D762AWP0305000Implant-OneAWP-0305-002020-09-02
D762AWP0310000Implant-OneAWP-0310-002020-09-02
D762AWP0320000Implant-OneAWP-0320-002020-09-02
D762AWP0330000Implant-OneAWP-0330-002020-09-02
D762AWP0340000Implant-OneAWP-0340-002020-09-02
D762AWP0350000Implant-OneAWP-0350-002020-09-02
D762AWP0405000Implant-OneAWP-0405-002020-09-02
D762AWP0410000Implant-OneAWP-0410-002020-09-02
D762AWP0420000Implant-OneAWP-0420-002020-09-02
D762AWP0430000Implant-OneAWP-0430-002020-09-02
D762AWP0440000Implant-OneAWP-0440-002020-09-02
D762AWP0450000Implant-OneAWP-0450-002020-09-02
D762AWP0505000Implant-OneAWP-0505-002020-09-02
D762AWP0510000Implant-OneAWP-0510-002020-09-02
D762AWP0520000Implant-OneAWP-0520-002020-09-02
D762AWP0530000Implant-OneAWP-0530-002020-09-02
D762AWP0540000Implant-OneAWP-0540-002020-09-02
D762AWP0550000Implant-OneAWP-0550-002020-09-02
D762CSR0300000Implant-OneCSR-0300-002020-06-30
D762CSR0400000Implant-OneCSR-0400-002020-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08806395200535Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
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08806395200702Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
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08806395200740Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
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08806395200764Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200771Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200788Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200795Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200801Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200818Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200825Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28