FDA.report

Implant-One

Primary DI
D762IOS0350001
Brand
Implant-One
Company
Implant Logistics, Inc.
Model
IOS-0350-00
Device description
3.5mm Implant Osteotomy Shaper
Published
2020-08-12
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
false

Related Records

Contact Domains

Product Codes

CodeName
DZIDrill, Bone, Powered

Product Code Classifications

CodeDeviceSpecialtyClass
DZIDrill, Bone, PoweredDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D762IOS0350001PrimaryHIBCC0

GMDN Terms

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
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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D762IPC034500M0Implant-OneIPC-0345-00M2024-12-06
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D762IPO034500M0Implant-OneIPO-0345-00M2024-12-06
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D762MUA031000M0Implant-OneMUA-0310-00M2024-12-06
D762MUA032000M0Implant-OneMUA-0320-00M2024-12-06
D762MUA032517M0Implant-OneMUA-0325-17M2024-12-06
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D762MUA033000M0Implant-OneMUA-0330-00M2024-12-06
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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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