FDA.reportPublic FDA data

Straight Drill

Primary DI
08806388239412
Brand
Straight Drill
Company
Megagen Implant Co. Ltd
Model
TEED380M
Catalog number
TEED380M
Device description
Common Ø3.8/ L=18.5
Published
2015-06-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
08806388239412PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806388239412088063882394128806388239412

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
687388178
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08806388243662Multi-unit Abutment PackageMUAAOH1725MUAAOH1725P2021-11-18
08806388243679Multi-unit Abutment PackageMUAAOH1735MUAAOH1735P2021-11-18
08806388243686Multi-unit Abutment PackageMUAAOH3035MUAAOH3035P2021-11-18
08806388243693Multi-unit Abutment PackageMUAAOH3045MUAAOH3045P2021-11-18
08806388243709Multi-unit Abutment PackageMUAAON1725MUAAON1725P2021-11-18
08806388243747Multi-unit Abutment PackageMUAAON0015MUAAON0015P2021-11-18
08806388243754Multi-unit Abutment PackageMUAAON0025MUAAON0025P2021-11-18
08806388243761Multi-unit Abutment PackageMUAAON0035MUAAON0035P2021-11-18
08806388243778Multi-unit Abutment PackageMUAAON0045MUAAON0045P2021-11-18
08806388243785Multi-unit Abutment PackageMUAARH1725MUAARH1725P2021-11-18
08806388243792Multi-unit Abutment PackageMUAARH1735MUAARH1735P2021-11-18
08806388243808Multi-unit Abutment PackageMUAARH3035MUAARH3035P2021-11-18
08806388243815Multi-unit Abutment PackageMUAARH3045MUAARH3045P2021-11-18
08806388243822Multi-unit Abutment PackageMUAARN0015MUAARN0015P2021-11-18
08806388243839Multi-unit Abutment PackageMUAARN0025MUAARN0025P2021-11-18
08806388243846Multi-unit Abutment PackageMUAARN0035MUAARN0035P2021-11-18
08806388243853Multi-unit Abutment PackageMUAARN0045MUAARN0045P2021-11-18
08806388243860Multi-unit Abutment PackageMUAARN1725MUAARN1725P2021-11-18
08806388243877Multi-unit Abutment PackageMUAARN1735MUAARN1735P2021-11-18
08806388243884Multi-unit Abutment PackageMUAARN3035MUAARN3035P2021-11-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290109748054Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290109748061Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290109748078Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290109748085Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290109748092Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290109748108Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290109748115Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290116660882Surgical ToolsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNDP2026-07-12
07290116660899Surgical ToolsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNDP2026-07-12
07290116660981Surgical ToolsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNDP2026-07-12
08800313235715SQ AXEL Guide CountersinkDENTIS CO. ,LTDNDP2026-07-09
08800313235722SQ AXEL Guide CountersinkDENTIS CO. ,LTDNDP2026-07-09
08800313235739SQ AXEL Guide CountersinkDENTIS CO. ,LTDNDP2026-07-09
08800313235746SQ AXEL Guide CountersinkDENTIS CO. ,LTDNDP2026-07-09
08800313235753SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235760SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235777SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235784SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235791SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235807SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235814SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235821SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235838SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235845SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235852SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235869SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235876SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235883SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235890SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235906SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09