FDA.report

Implant-One

Primary DI
D762SD520181
Brand
Implant-One
Company
Implant Logistics, Inc.
Model
SD52018
Device description
Surgical Drill, 05.20mm x 18mm Depth
Published
2016-05-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
DZIDrill, Bone, Powered

Product Code Classifications

CodeDeviceSpecialtyClass
DZIDrill, Bone, PoweredDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D762SD520181PrimaryHIBCC0

GMDN Terms

TermDefinition
Fixture/appliance dental drill bit, reusableA shaft of metal intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a manual or power tool handpiece that provides rotation. 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
true
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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