36114

GUDID 07332747014471

Drill Tapered RP 4.3x11.5 mm

Nobel Biocare AB

Fixture/appliance dental drill bit, reusable
Primary Device ID07332747014471
NIH Device Record Keyfb11d79f-8e65-4673-b5ea-997a3ce4c8d8
Commercial Distribution StatusIn Commercial Distribution
Version Model Number36114
Catalog Number36114
Company DUNS353939929
Company NameNobel Biocare AB
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datefalse
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)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com

Device Dimensions

Outer Diameter4.3 Millimeter
Outer Diameter4.3 Millimeter
Length11.5 Millimeter
Outer Diameter4.3 Millimeter
Length11.5 Millimeter
Outer Diameter4.3 Millimeter
Length11.5 Millimeter
Outer Diameter4.3 Millimeter
Length11.5 Millimeter
Outer Diameter4.3 Millimeter
Length11.5 Millimeter
Outer Diameter4.3 Millimeter
Length11.5 Millimeter
Outer Diameter4.3 Millimeter
Length11.5 Millimeter
Outer Diameter4.3 Millimeter
Length11.5 Millimeter
Outer Diameter4.3 Millimeter
Length11.5 Millimeter
Outer Diameter4.3 Millimeter
Length11.5 Millimeter
Outer Diameter4.3 Millimeter
Length11.5 Millimeter
Outer Diameter4.3 Millimeter
Length11.5 Millimeter
Outer Diameter4.3 Millimeter
Length11.5 Millimeter
Outer Diameter4.3 Millimeter
Length11.5 Millimeter
Outer Diameter4.3 Millimeter
Length11.5 Millimeter
Outer Diameter4.3 Millimeter
Length11.5 Millimeter
Outer Diameter4.3 Millimeter
Length11.5 Millimeter
Outer Diameter4.3 Millimeter
Length11.5 Millimeter
Outer Diameter4.3 Millimeter
Length11.5 Millimeter
Outer Diameter4.3 Millimeter
Length11.5 Millimeter
Outer Diameter4.3 Millimeter
Length11.5 Millimeter
Outer Diameter4.3 Millimeter
Length11.5 Millimeter
Outer Diameter4.3 Millimeter
Length11.5 Millimeter
Outer Diameter4.3 Millimeter
Length11.5 Millimeter
Outer Diameter4.3 Millimeter
Length11.5 Millimeter
Outer Diameter4.3 Millimeter
Length11.5 Millimeter
Outer Diameter4.3 Millimeter
Length11.5 Millimeter
Outer Diameter4.3 Millimeter
Length11.5 Millimeter
Outer Diameter4.3 Millimeter
Length11.5 Millimeter
Outer Diameter4.3 Millimeter
Length11.5 Millimeter
Outer Diameter4.3 Millimeter
Length11.5 Millimeter
Outer Diameter4.3 Millimeter
Length11.5 Millimeter
Outer Diameter4.3 Millimeter
Length11.5 Millimeter
Outer Diameter4.3 Millimeter
Length11.5 Millimeter
Outer Diameter4.3 Millimeter
Length11.5 Millimeter
Outer Diameter4.3 Millimeter
Length11.5 Millimeter
Outer Diameter4.3 Millimeter
Length11.5 Millimeter
Outer Diameter4.3 Millimeter
Length11.5 Millimeter
Outer Diameter4.3 Millimeter
Length11.5 Millimeter
Outer Diameter4.3 Millimeter
Length11.5 Millimeter
Outer Diameter4.3 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107332747014471 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZIDRILL, BONE, POWERED
NDPAccessories, implant, dental, endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07332747014471]

Moist Heat or Steam Sterilization


[07332747014471]

Moist Heat or Steam Sterilization


[07332747014471]

Moist Heat or Steam Sterilization


[07332747014471]

Moist Heat or Steam Sterilization


[07332747014471]

Moist Heat or Steam Sterilization


[07332747014471]

Moist Heat or Steam Sterilization


[07332747014471]

Moist Heat or Steam Sterilization


[07332747014471]

Moist Heat or Steam Sterilization


[07332747014471]

Moist Heat or Steam Sterilization


[07332747014471]

Moist Heat or Steam Sterilization


[07332747014471]

Moist Heat or Steam Sterilization


[07332747014471]

Moist Heat or Steam Sterilization


[07332747014471]

Moist Heat or Steam Sterilization


[07332747014471]

Moist Heat or Steam Sterilization


[07332747014471]

Moist Heat or Steam Sterilization


[07332747014471]

Moist Heat or Steam Sterilization


[07332747014471]

Moist Heat or Steam Sterilization


[07332747014471]

Moist Heat or Steam Sterilization


[07332747014471]

Moist Heat or Steam Sterilization


[07332747014471]

Moist Heat or Steam Sterilization


[07332747014471]

Moist Heat or Steam Sterilization


[07332747014471]

Moist Heat or Steam Sterilization


[07332747014471]

Moist Heat or Steam Sterilization


[07332747014471]

Moist Heat or Steam Sterilization


[07332747014471]

Moist Heat or Steam Sterilization


[07332747014471]

Moist Heat or Steam Sterilization


[07332747014471]

Moist Heat or Steam Sterilization


[07332747014471]

Moist Heat or Steam Sterilization


[07332747014471]

Moist Heat or Steam Sterilization


[07332747014471]

Moist Heat or Steam Sterilization


[07332747014471]

Moist Heat or Steam Sterilization


[07332747014471]

Moist Heat or Steam Sterilization


[07332747014471]

Moist Heat or Steam Sterilization


[07332747014471]

Moist Heat or Steam Sterilization


[07332747014471]

Moist Heat or Steam Sterilization


[07332747014471]

Moist Heat or Steam Sterilization


[07332747014471]

Moist Heat or Steam Sterilization


[07332747014471]

Moist Heat or Steam Sterilization


[07332747014471]

Moist Heat or Steam Sterilization


[07332747014471]

Moist Heat or Steam Sterilization


[07332747014471]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-01-09
Device Publish Date2016-09-17

Devices Manufactured by Nobel Biocare AB

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07332747221183 - DTX Studio™ Clinic2025-05-02 DTX Studio Clinic 4.5 for Win 64-bit
07332747221190 - DTX Studio™ Clinic2025-05-02 DTX Studio Clinic 4.5 for Mac
07332747225426 - NA2025-05-02 Nobel Dummy Material for FDA Integration
07332747150377 - Nobel Biocare®2025-04-30 Coping Screw Hex 2mm 4/pkg
07332747207842 - Nobel Biocare®2025-04-03 Direct Abutment Engaging Gold/Plastic 5.0 HL/RPL
07332747207859 - Nobel Biocare®2025-04-03 Direct Abutment Non-Engaging Gold/Plastic 5.0 HL/RPL

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