FDA.report

Implant-One

Primary DI
D762IPC0400000
Brand
Implant-One
Company
Implant Logistics, Inc.
Model
IPC-0400-00
Device description
400 Series Closed Tray Impression Post
Published
2022-06-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D762IPC0400000PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental implant suprastructure, temporary, preformed, single-useA prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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

Regulatory Flags

DUNS number
079280537
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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D762IPC0345000Implant-OneIPC-0345-002024-12-06
D762IPC034500M0Implant-OneIPC-0345-00M2024-12-06
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D762MUA032000M0Implant-OneMUA-0320-00M2024-12-06
D762MUA032517M0Implant-OneMUA-0325-17M2024-12-06
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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