Nobel Biocare N1™ 300883

GUDID 07332747161953

OsseoShaper 1 Nobel Biocare N1™ 3.5x13mm

Nobel Biocare AB

Fixture/appliance dental drill bit, single-use Fixture/appliance dental drill bit, single-use Fixture/appliance dental drill bit, single-use Fixture/appliance dental drill bit, single-use Fixture/appliance dental drill bit, single-use Fixture/appliance dental drill bit, single-use Fixture/appliance dental drill bit, single-use Fixture/appliance dental drill bit, single-use Fixture/appliance dental drill bit, single-use Fixture/appliance dental drill bit, single-use Fixture/appliance dental drill bit, single-use Fixture/appliance dental drill bit, single-use Fixture/appliance dental drill bit, single-use Fixture/appliance dental drill bit, single-use Fixture/appliance dental drill bit, single-use Fixture/appliance dental drill bit, single-use Fixture/appliance dental drill bit, single-use Fixture/appliance dental drill bit, single-use Fixture/appliance dental drill bit, single-use Fixture/appliance dental drill bit, single-use Fixture/appliance dental drill bit, single-use Fixture/appliance dental drill bit, single-use Fixture/appliance dental drill bit, single-use Fixture/appliance dental drill bit, single-use Fixture/appliance dental drill bit, single-use Fixture/appliance dental drill bit, single-use
Primary Device ID07332747161953
NIH Device Record Keyd4240571-4632-4d19-a1d6-2bfd02ea5125
Commercial Distribution StatusIn Commercial Distribution
Brand NameNobel Biocare N1™
Version Model Number300883
Catalog Number300883
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
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

Device Dimensions

Outer Diameter3.5 Millimeter
Length13 Millimeter
Outer Diameter3.5 Millimeter
Length13 Millimeter
Outer Diameter3.5 Millimeter
Length13 Millimeter
Outer Diameter3.5 Millimeter
Length13 Millimeter
Outer Diameter3.5 Millimeter
Length13 Millimeter
Outer Diameter3.5 Millimeter
Length13 Millimeter
Outer Diameter3.5 Millimeter
Length13 Millimeter
Outer Diameter3.5 Millimeter
Length13 Millimeter
Outer Diameter3.5 Millimeter
Length13 Millimeter
Outer Diameter3.5 Millimeter
Length13 Millimeter
Outer Diameter3.5 Millimeter
Length13 Millimeter
Outer Diameter3.5 Millimeter
Length13 Millimeter
Outer Diameter3.5 Millimeter
Length13 Millimeter
Outer Diameter3.5 Millimeter
Length13 Millimeter
Outer Diameter3.5 Millimeter
Length13 Millimeter
Outer Diameter3.5 Millimeter
Length13 Millimeter
Outer Diameter3.5 Millimeter
Length13 Millimeter
Outer Diameter3.5 Millimeter
Length13 Millimeter
Outer Diameter3.5 Millimeter
Length13 Millimeter
Outer Diameter3.5 Millimeter
Length13 Millimeter
Outer Diameter3.5 Millimeter
Length13 Millimeter
Outer Diameter3.5 Millimeter
Length13 Millimeter
Outer Diameter3.5 Millimeter
Length13 Millimeter
Outer Diameter3.5 Millimeter
Length13 Millimeter
Outer Diameter3.5 Millimeter
Length13 Millimeter
Outer Diameter3.5 Millimeter
Length13 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry

Device Identifiers

Device Issuing AgencyDevice ID
GS107332747161953 [Primary]

FDA Product Code

QRQNon-irrigation endosseous dental implant drill bits

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-16
Device Publish Date2022-05-06

On-Brand Devices [Nobel Biocare N1™]

07332747192476Temporary Abutment Nobel Biocare N1™ TCC RP 3.0mm
07332747192360OsseoShaper 2 Nobel Biocare N1™ 4.0x11mm
07332747177817Screwdriver Manual Nobel Biocare N1™ Base 36mm
07332747177800Screwdriver Manual Nobel Biocare N1™ Base 28mm
07332747177794Rescue Drill Guide Nobel Biocare N1™ TCC RP
07332747177770Screwdriver Manual Omnigrip™ Mini 36mm
07332747177763Screwdriver Manual Omnigrip™ Mini 20mm
07332747177237Position Locator Nobel Biocare N1™ Base Tri RP
07332747177220Position Locator Nobel Biocare N1™ Base Tri NP
07332747177190Lab Screw Nobel Biocare N1™ Base RP
07332747177183Lab Screw Nobel Biocare N1™ Base NP
07332747177169IOS Base Replica Nobel Biocare N1™ Base Tri RP
07332747177152IOS Base Replica Nobel Biocare N1™ Base Tri NP
07332747177145Base Replica Nobel Biocare N1™ Base Tri RP
07332747177138Base Replica Nobel Biocare N1™ Base Tri NP
07332747177114Impression Coping Closed Tray Nobel Biocare N1™ Base Tri RP
07332747177107Impression Coping Closed Tray Nobel Biocare N1™ Base Tri NP
07332747177084Impression Coping Open Tray Nobel Biocare N1™ Base Tri RP
07332747177077Impression Coping Open Tray Nobel Biocare N1™ Base Tri NP
07332747177060Position Locator Nobel Biocare N1™ TCC RP
07332747177053Position Locator Nobel Biocare N1™ TCC NP
07332747177022Lab Screw Nobel Biocare N1™ TCC RP
07332747177015Lab Screw Nobel Biocare N1™ TCC NP
07332747177008IOS Implant Replica Nobel Biocare N1™ TCC RP
07332747176995IOS Implant Replica Nobel Biocare N1™ TCC NP
07332747176988Implant Replica Nobel Biocare N1™ TCC RP
07332747176971Implant Replica Nobel Biocare N1™ TCC NP
07332747176940Impression Cop Closed Tray Nobel Biocare N1™ TCC RP 4.5x9mm
07332747176933Impression Cop Closed Tray Nobel Biocare N1™ TCC RP 4.5x13mm
07332747176926Impression Cop Closed Tray Nobel Biocare N1™ TCC NP 4x13mm
07332747176896Impression Cop Open Tray Nobel Biocare N1™ TCC RP 4.5x10mm
07332747176889Impression Cop Open Tray Nobel Biocare N1™ TCC RP 4.5x14mm
07332747176872Impression Cop Open Tray Nobel Biocare N1™ TCC NP 4x14mm
07332747176858Abutment Retrieval Tool Nobel Biocare N1™ TCC RP
07332747176841Abutment Retrieval Tool Nobel Biocare N1™ TCC NP
07332747176834Rescue Drill Guide Nobel Biocare N1™ TCC NP
07332747176827Direction Indicator Nobel Biocare N1™
07332747176810Bone Mill Guide Nobel Biocare N1™ TCC RP Ø5.2
07332747176803Bone Mill Guide Nobel Biocare N1™ TCC NP Ø5.2
07332747176780Bone Mill Guide Nobel Biocare N1™ TCC NP Ø4.0
07332747167351Screw Tap Repair Tool Nobel Biocare N1™ TCC RP
07332747167344Screw Tap Repair Tool Nobel Biocare N1™ TCC NP
07332747167221Screwdriver Manual Nobel Biocare N1™ Base 36mm
07332747167214Screwdriver Manual Nobel Biocare N1™ Base 28mm
07332747163964Clinical Screw Nobel Biocare N1™ TCC RP
07332747163919Radiographic Template Nobel Biocare N1™
07332747163780Universal Abutment Nobel Biocare N1™ Base Tri RP Bridge
07332747163773Universal Abutment Nobel Biocare N1™ Base Tri NP Bridge
07332747163759Universal Abutment Nobel Biocare N1™ Base Tri RP
07332747163742Universal Abutment Nobel Biocare N1™ Base Tri NP

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.