FDA.report

Neobiotech Implant System

Primary DI
08809876901129
Brand
Neobiotech Implant System
Company
Neobiotech. co., ltd
Model
EZSD4113
Device description
Ø4.1 L:13.0mm
Published
2022-11-30
Public version status
New
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
DZADrill, Dental, Intraoral

Product Code Classifications

CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08809876901129PrimaryGS10

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

Regulatory Flags

DUNS number
688371566
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
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 DIBrandModelCatalogPublished
08809876904793Neobiotech Implant SystemISPTC4402026-03-04
08809876904885Neobiotech Implant SystemISPTC5402026-03-04
08809876904892Neobiotech Implant SystemISPTC6402026-03-04
08809486290101Neobiotech Implant SystemMUAHC482026-02-25
08809486293515Neobiotech Implant SystemIS35006AP2026-02-25
08809486293522Neobiotech Implant SystemIS35506AP2026-02-25
08809737570167Neobiotech Implant SystemIS36006AP2026-02-25
08809737570174Neobiotech Implant SystemIS35006A2026-02-25
08809737570181Neobiotech Implant SystemIS35506A2026-02-25
08809737570198Neobiotech Implant SystemIS36006A2026-02-25
08809737575360Neobiotech Implant SystemMUAS142026-02-25
08809737575391Neobiotech Implant SystemMUATPCN482026-02-25
08809737575407Neobiotech Implant SystemISANMUA3440S2026-02-25
08809737575414Neobiotech Implant SystemISANMUA3430S2026-02-25
08809737575421Neobiotech Implant SystemISANMUA3420S2026-02-25
08809737575438Neobiotech Implant SystemISANMUA3410S2026-02-25
08809737575445Neobiotech Implant SystemISANMUA1440S2026-02-25
08809737575452Neobiotech Implant SystemISANMUA1430S2026-02-25
08809737575469Neobiotech Implant SystemISANMUA1420S2026-02-25
08809737575476Neobiotech Implant SystemISANMUA1410S2026-02-25

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