36115

GUDID 07332747014495

Drill Tapered WP 5.0x11.5 mm

Nobel Biocare AB

Fixture/appliance dental drill bit, reusable Fixture/appliance dental drill bit, reusable Fixture/appliance dental drill bit, reusable Fixture/appliance dental drill bit, reusable Fixture/appliance dental drill bit, reusable Fixture/appliance dental drill bit, reusable Fixture/appliance dental drill bit, reusable Fixture/appliance dental drill bit, reusable Fixture/appliance dental drill bit, reusable Fixture/appliance dental drill bit, reusable Fixture/appliance dental drill bit, reusable Fixture/appliance dental drill bit, reusable Fixture/appliance dental drill bit, reusable Fixture/appliance dental drill bit, reusable Fixture/appliance dental drill bit, reusable Fixture/appliance dental drill bit, reusable Fixture/appliance dental drill bit, reusable Fixture/appliance dental drill bit, reusable Fixture/appliance dental drill bit, reusable Fixture/appliance dental drill bit, reusable Fixture/appliance dental drill bit, reusable Fixture/appliance dental drill bit, reusable Fixture/appliance dental drill bit, reusable Fixture/appliance dental drill bit, reusable Fixture/appliance dental drill bit, reusable Fixture/appliance dental drill bit, reusable Fixture/appliance dental drill bit, reusable Fixture/appliance dental drill bit, reusable Fixture/appliance dental drill bit, reusable Fixture/appliance dental drill bit, reusable Fixture/appliance dental drill bit, reusable
Primary Device ID07332747014495
NIH Device Record Key8879ce69-4f63-4a3e-aa7f-f49065dc71fb
Commercial Distribution StatusIn Commercial Distribution
Version Model Number36115
Catalog Number36115
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

Device Dimensions

Length11.5 Millimeter
Length11.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter
Outer Diameter5 Millimeter
Length11.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107332747014495 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZIDRILL, BONE, POWERED

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07332747014495]

Moist Heat or Steam Sterilization

[07332747014495]

Moist Heat or Steam Sterilization

[07332747014495]

Moist Heat or Steam Sterilization

[07332747014495]

Moist Heat or Steam Sterilization

[07332747014495]

Moist Heat or Steam Sterilization

[07332747014495]

Moist Heat or Steam Sterilization

[07332747014495]

Moist Heat or Steam Sterilization

[07332747014495]

Moist Heat or Steam Sterilization

[07332747014495]

Moist Heat or Steam Sterilization

[07332747014495]

Moist Heat or Steam Sterilization

[07332747014495]

Moist Heat or Steam Sterilization

[07332747014495]

Moist Heat or Steam Sterilization

[07332747014495]

Moist Heat or Steam Sterilization

[07332747014495]

Moist Heat or Steam Sterilization

[07332747014495]

Moist Heat or Steam Sterilization

[07332747014495]

Moist Heat or Steam Sterilization

[07332747014495]

Moist Heat or Steam Sterilization

[07332747014495]

Moist Heat or Steam Sterilization

[07332747014495]

Moist Heat or Steam Sterilization

[07332747014495]

Moist Heat or Steam Sterilization

[07332747014495]

Moist Heat or Steam Sterilization

[07332747014495]

Moist Heat or Steam Sterilization

[07332747014495]

Moist Heat or Steam Sterilization

[07332747014495]

Moist Heat or Steam Sterilization

[07332747014495]

Moist Heat or Steam Sterilization

[07332747014495]

Moist Heat or Steam Sterilization

[07332747014495]

Moist Heat or Steam Sterilization

[07332747014495]

Moist Heat or Steam Sterilization

[07332747014495]

Moist Heat or Steam Sterilization

[07332747014495]

Moist Heat or Steam Sterilization

[07332747014495]

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

07332747215052 - Nobel Biocare®2024-06-28 Nobel Biocare Multi-unit PoLo 8mm
07332747215069 - Nobel Biocare®2024-06-28 Nobel Biocare Multi-unit PoLo Bmk WP 8mm
07332747215076 - Nobel Biocare®2024-06-28 Nobel Biocare Multi-unit PoLo Link 10mm
07332747215083 - Nobel Biocare®2024-06-28 Nobel Biocare Multi-unit PoLo Link 15mm
07332747215090 - Nobel Biocare®2024-06-28 Nobel Biocare Multi-unit PoLo Link 20mm
07332747215106 - Nobel Biocare®2024-06-28 Nobel Biocare ReverseScan Multi-unit
07332747215113 - Nobel Biocare®2024-06-28 Nobel Biocare ReverseScan Multi-unit Bmk WP
07332747218008 - Nobel Biocare®2024-06-28 Nobel Biocare Multi-unit PoLo Prosthetic Screw 5/pkg
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.