FDA.report

Implant-One

Primary DI
D762IR55508000
Brand
Implant-One
Company
Implant Logistics, Inc.
Model
IR5-5508-00
Device description
500 Series Standard Thread, Root Form Implant, 5.5mm Diameter x 8mm Length. Included with the implant is the matching, sterile packed, carrier and cover screw.
Published
2020-08-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications

CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D762IR55508000PrimaryHIBCC0

GMDN Terms

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

Contacts

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

Regulatory Flags

DUNS number
079280537
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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

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D762IPC034500M0Implant-OneIPC-0345-00M2024-12-06
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D762MUA032530M0Implant-OneMUA-0325-30M2024-12-06
D762MUA033000M0Implant-OneMUA-0330-00M2024-12-06
D762MUA033517M0Implant-OneMUA-0335-17M2024-12-06
D762MUA033530M0Implant-OneMUA-0335-30M2024-12-06
D762MUA034000M0Implant-OneMUA-0340-00M2024-12-06
D762MUA0345HCM0Implant-OneMUA-0345-HCM2024-12-06
D762MUA0345PTM0Implant-OneMUA-0345-PTM2024-12-06
D762MUA0345SBM0Implant-OneMUA-0345-SBM2024-12-06
D762MUA0345TBM0Implant-OneMUA-0345-TBM2024-12-06
D762MUA0345VCM0Implant-OneMUA-0345-VCM2024-12-06

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