osseolink Implant

GUDID 00816273020504

Drill-ø 3.9 mm-Long

OSSEOLINK USA LLC

Dental drilling system attachment
Primary Device ID00816273020504
NIH Device Record Key79d81b70-dcbe-42d6-9869-107500c2dab4
Commercial Distribution StatusIn Commercial Distribution
Brand Nameosseolink Implant
Version Model NumberTD39L
Company DUNS080083007
Company NameOSSEOLINK USA LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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(877)677-3688
Emailinfo@osseolink.com
Phone+1(877)677-3688
Emailinfo@osseolink.com
Phone+1(877)677-3688
Emailinfo@osseolink.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100816273020504 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEIMPLANT, ENDOSSEOUS, ROOT-FORM

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00816273020504]

Radiation Sterilization

[00816273020504]

Radiation Sterilization

[00816273020504]

Radiation Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-05-18

On-Brand Devices [osseolink Implant]

00816273020757Surgical Tray (no instruments)
00816273020740Surgical Tray with Instrument set
00816273020733Parallel Pin
00816273020726Implant Placement Guide
00816273020719Double Ended Depth Gauge
00816273020702Driver Extension
00816273020696Universal Implant Driver
00816273020689Variable Torque Wrench
00816273020672Driver Adapter
00816273020665Hex Driver 0.05" (1.25 mm)
00816273020658Tap Drill ø 5.0 mm
00816273020641Tap Drill ø 4.0 mm
00816273020634Tap Drill ø 3.5 mm
00816273020627Countersink Drill ø 5.0 mm
00816273020610Countersink Drill ø 4.5 mm
00816273020603Countersink Drill ø 3.5 mm
00816273020597Step Drill ø 5.0 mm
00816273020580Step Drill ø 4.0 mm
00816273020573Step Drill ø 3.5 mm
00816273020566Drill- ø 2.8 mm-Short
00816273020559Drill- ø 2.2 mm-Short
00816273020542Drill-ø 4.9 mm-Long
00816273020535Drill-ø 4.9 mm-Short
00816273020528Drill-ø 4.3 mm-Long
00816273020511Drill-ø 4.3 mm-Short
00816273020504Drill-ø 3.9 mm-Long
00816273020498Drill-ø 3.9 mm-Short
00816273020481Drill-ø 3.3 mm-Long
00816273020474Drill-ø 3.3 mm-Short
00816273020467Drill- ø 2.5 mm-Long
00816273020450Drill- ø 2.5 mm-Short
00816273020443Drill- ø 2.0 mm-Long
00816273020436Drill- ø 2.0 mm-Short
00816273020429Lindemann Surgical Bur
00816273020412Round Bur
00816273020405Healing Abutments ø 6.0 mm,5.0 mm (H)
00816273020399Healing Abutments ø 6.0 mm,3.0 mm (H)
00816273020382Healing Abutments ø 5.0 mm,5.0 mm (H)
00816273020375Healing Abutments ø 5.0 mm,3.0 mm (H)
00816273020368Healing Abutments ø 4.0 mm,5.0 mm (H)
00816273020351Healing Abutments ø 4.0 mm,3.0 mm (H)
00816273020344Angled Abutment ø 5.5
00816273020337Angled Abutment ø 4.5
00816273020320Combination Abutment
00816273020313Non anatomic Abutment-Titanium ø 5.5 mm,4.0 mm (H)
00816273020306Non anatomic Abutment-Titanium ø 5.5 mm,0.5 mm (H)
00816273020290Non anatomic Abutment-Titanium ø 5.5 mm,2.0 mm (H)
00816273020283Non anatomic Abutment-Titanium ø 4.5 mm,4.0 mm (H)
00816273020276Non anatomic Abutment-Titanium ø 4.5 mm, 0.5 mm (H)
00816273020269Non anatomic Abutment-Titanium ø 4.5 mm,2.0 mm (H)
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