FDA.reportPublic FDA data

Twist Drill D=2.00mm,L=7.5mm

Primary DI
07290112280961
Brand
Twist Drill D=2.00mm,L=7.5mm
Company
DENTACK IMPLANTS LTD
Model
TSD-207
Device description
Twist Drill D=2.00mm,L=7.5mm
Published
2019-03-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZADrill, Dental, Intraoral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290112280961PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290112280961072901122809617290112280961

GMDN Terms#

Term, Definition table
TermDefinition
Fluted surgical drill bit, reusableA shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+97297660379info@pyramidion-is.com

Regulatory Flags#

DUNS number
514897185
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290112280824ET-1250ET-12502019-03-02
07290112280831Expansion tool-screw 6.35+wrench short - AssyET-18502019-03-02
07290112280848Expansion tool EX-screw 6.35+wrench long-AssyET-1250EX2019-03-02
07290112280855Expansion tool EX-screw+wrench short - AssyET-1850EX2019-03-02
07290112280862Long Driver 1.25DL-1252019-03-02
07290112280879Short Driver 1.25DS-1252019-03-02
07290112280886Hand Driver for Cover ScrewHD092019-03-02
07290112280893Insertion Tool Long 2.5ITL-2502019-03-02
07290112280909Insertion Tool Short 2.5ITS-2502019-03-02
07290112280916"Torque Ratchet Hex 1/4"" Wheel"RT-35002019-03-02
07290112280541Impression copingsIC-7502018-02-23
07290112280664Implant 4.1*5EDI-41052019-02-27
07290112280671Straight MU AbutmentMU-412N2019-02-27
07290112280688Multi Unit Abutment for EXMU-412EXN2019-02-26
07290112280695Straight MU AbutmentMU-413N2019-02-27
07290112280701Multi Unit Abutment for EXMU-413EXN2019-02-26
07290112280718Straight MU AbutmentMU-414N2019-02-27
07290112280725Multi Unit Abutment for EXMU-414EXN2019-02-26
07290112280732Angled MU abutment MU-17152019-02-27
07290112280749Angled MU abutment 17-1.5 for EXMU-1715EX2019-02-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290116154787Dental DrillsNORIS MEDICAL LTDDZA2026-07-09
07290116154794Diamond BurrsNORIS MEDICAL LTDDZA2026-07-09
088000702492151.2 Hex Angled Machine Screw DriverIzenimplant Co., Ltd.DZA2026-06-22
06932195393831DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195393848DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195393855DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195393879DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195393886DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195393909DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195393916DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195393923DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195393930DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195393954DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195393961DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195393985DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195393992DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195394012DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195395002DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195395019DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195395026DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195395033DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195395040DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195395057DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195395064DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195395071DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195395088DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195395095DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195395101DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195395118DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195395125DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10