FDA.reportPublic FDA data

Implant-One

Primary DI
D762EXT0080001
Brand
Implant-One
Company
Implant Logistics, Inc.
Model
EXT-0080-00
Device description
Extractor, Abutment 0-80
Published
2020-09-02
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D762EXT0080001PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant extractorA manually-operated, one-piece dental device intended to be used to retrieve an in situ dental implant [i.e., anchorage and/or retention (abutment) component], typically because of damage (e.g., a broken collar) or malfunction, from the oral cavity. It typically has a cylindrical design and a cavity or threaded shaft at the working distal end intended to grip or be inserted into the implant. It may have a handle at the proximal end or be used in conjunction with a drill and/or a separate handle or wrench (not included); it is not a collection of devices (i.e., not a kit). This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D762DEN0345SB0Implant-OneDEN-0345-SB2025-02-28
D762ALG034500M0Implant-OneALG-0345-00M2024-12-06
D762IPC0345000Implant-OneIPC-0345-002024-12-06
D762IPC034500M0Implant-OneIPC-0345-00M2024-12-06
D762IPO0345000Implant-OneIPO-0345-002024-12-06
D762IPO034500M0Implant-OneIPO-0345-00M2024-12-06
D762MUA030500M0Implant-OneMUA-0305-00M2024-12-06
D762MUA031000M0Implant-OneMUA-0310-00M2024-12-06
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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Primary DI, Brand, Company table
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08800020803030SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
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