FDA.reportPublic FDA data

Implant-One

Primary DI
D762KITBOPR000
Brand
Implant-One
Company
Implant Logistics, Inc.
Model
KIT-BOPR-00
Device description
Bone Profiler Kit
Published
2021-05-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
KMWHandpiece, Rotary Bone Cutting
NDPAccessories, Implant, Dental, Endosseous
OFYDental Implant Surgical Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMWHandpiece, Rotary Bone CuttingDental2
NDPAccessories, Implant, Dental, EndosseousDental1
OFYDental Implant Surgical TrayDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D762KITBOPR000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure reamerA manually-operated dental laboratory instrument intended to be used to smooth and refine the surface of the screw channel, screw seat and implant/abutment connection of a dental implant suprastructure, by means of a rotating abrasive action. It is used to remove minor casting flashes on the mating surface of the suprastructure during the production of a final suprastructure; it is not intended for intraoral use. It is in the form of a metallic cylinder which may be cannulated, and is available in various diameters and sizes. This is a reusable 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
Premarket exempt
true
Kit
true
Lot or batch
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D762MUA030500M0Implant-OneMUA-0305-00M2024-12-06
D762MUA031000M0Implant-OneMUA-0310-00M2024-12-06
D762MUA032000M0Implant-OneMUA-0320-00M2024-12-06
D762MUA033000M0Implant-OneMUA-0330-00M2024-12-06
D762MUA034000M0Implant-OneMUA-0340-00M2024-12-06
D762MUA0345HCM0Implant-OneMUA-0345-HCM2024-12-06
D762MUA0345TBM0Implant-OneMUA-0345-TBM2024-12-06
D762MUA0345VCM0Implant-OneMUA-0345-VCM2024-12-06
D762MUA035000M0Implant-OneMUA-0350-00M2024-12-06
D762MUA040500M0Implant-OneMUA-0405-00M2024-12-06
D762MUA041000M0Implant-OneMUA-0410-00M2024-12-06
D762MUA042000M0Implant-OneMUA-0420-00M2024-12-06
D762MUA043000M0Implant-OneMUA-0430-00M2024-12-06
D762MUA044000M0Implant-OneMUA-0440-00M2024-12-06
D762MUA045000M0Implant-OneMUA-0450-00M2024-12-06
D762MUA050500M0Implant-OneMUA-0505-00M2024-12-06
D762MUA051000M0Implant-OneMUA-0510-00M2024-12-06
D762MUA052000M0Implant-OneMUA-0520-00M2024-12-06
D762MUA053000M0Implant-OneMUA-0530-00M2024-12-06
D762MUA054000M0Implant-OneMUA-0540-00M2024-12-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07392532032349Bone TrapDentsply Implants Manufacturing GmbHNDP2026-10-16
06009544052913N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-14
08809918259713LW OSS Abutment Lab AnalogOssvis Co., Ltd.NDP2026-10-13
08809918259720LW OSS Abutment Lab AnalogOssvis Co., Ltd.NDP2026-10-13
03700977513110SlimEUROTEKNIKANDP2026-10-12
03700977513363iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513370iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513387iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513394iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513400iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513417iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513424iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513431iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513448iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513455iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513462iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513639iFlag ReversoEUROTEKNIKANDP2026-10-12
07290116661322Surgical ToolsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNDP2026-10-11
00810157315762MUA PEEK Comfort CapParagon Implant Mfg., LLCNDP2026-10-09
06942799001100SHINING 3D®Shining 3D Tech Co., Ltd.NDP2026-10-09
07899878068143NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-10-09
07899878068150NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-10-09
07899878068167NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-10-09
07899878068174NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-10-09
06009544052876N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052883N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052890N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052906N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052920N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052937N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07