044.793

GUDID 07630031772633

Twist Drill PRO, Ø 3.5mm, long, L 42mm, stainless steel

Institut Straumann AG

Fixture/appliance dental drill bit, reusable
Primary Device ID07630031772633
NIH Device Record Keyb8616288-5aab-4876-9295-7e54ceb8a7c5
Commercial Distribution StatusIn Commercial Distribution
Version Model Numbersurgically Invasive Instruments
Catalog Number044.793
Company DUNS483599259
Company NameInstitut Straumann AG
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com

Device Dimensions

Outer Diameter3.5 Millimeter
Length42 Millimeter
Outer Diameter3.5 Millimeter
Length42 Millimeter
Outer Diameter3.5 Millimeter
Length42 Millimeter
Outer Diameter3.5 Millimeter
Length42 Millimeter
Outer Diameter3.5 Millimeter
Length42 Millimeter
Outer Diameter3.5 Millimeter
Length42 Millimeter
Outer Diameter3.5 Millimeter
Length42 Millimeter
Outer Diameter3.5 Millimeter
Length42 Millimeter
Outer Diameter3.5 Millimeter
Length42 Millimeter
Outer Diameter3.5 Millimeter
Length42 Millimeter
Outer Diameter3.5 Millimeter
Length42 Millimeter
Outer Diameter3.5 Millimeter
Length42 Millimeter
Outer Diameter3.5 Millimeter
Length42 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107630031772633 [Primary]

FDA Product Code

NDPAccessories, implant, dental, endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07630031772633]

Moist Heat or Steam Sterilization


[07630031772633]

Moist Heat or Steam Sterilization


[07630031772633]

Moist Heat or Steam Sterilization


[07630031772633]

Moist Heat or Steam Sterilization


[07630031772633]

Moist Heat or Steam Sterilization


[07630031772633]

Moist Heat or Steam Sterilization


[07630031772633]

Moist Heat or Steam Sterilization


[07630031772633]

Moist Heat or Steam Sterilization


[07630031772633]

Moist Heat or Steam Sterilization


[07630031772633]

Moist Heat or Steam Sterilization


[07630031772633]

Moist Heat or Steam Sterilization


[07630031772633]

Moist Heat or Steam Sterilization


[07630031772633]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-03
Device Publish Date2025-03-26

Devices Manufactured by Institut Straumann AG

07630031771599 - NA2025-12-10 BLC Profile Drill, FIBA compatible, Ø 4.0mm, L 26mm, stainless steel
07630031774194 - NA2025-12-10 Guiding Cylinder for Explantation, SC Ø 2.9mm, stainless steel
07630031774200 - NA2025-12-10 Guiding Cylinder for Explantation, NC Ø 3.3mm, stainless steel
07630031774217 - NA2025-12-10 Guiding Cylinder for Explantation, RC Ø 4.1mm, stainless steel
07630031774224 - NA2025-12-10 Guiding Cylinder for Explantation, RC Ø 4.8mm, stainless steel
07630031774231 - NA2025-12-10 Explantation Drill, short, for Ø 2.9 - 3.3mm, L 37mm, stainless steel
07630031774248 - NA2025-12-10 Explantation Drill, short, for Ø 3.5 - 3.75mm, L 37mm, stainless steel
07630031774255 - NA2025-12-10 Explantation Drill, short, for Ø 4.0 - 4.1mm, L 37mm, stainless steel

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.