Neoss Implant System 31142

GUDID 05060440331015

Ball Abutment 4.5 mm

Neoss Ltd

Screw endosteal dental implant, two-piece Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed
Primary Device ID05060440331015
NIH Device Record Keyb2d7778b-d9d3-43f0-b52a-02fa7cc412ae
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeoss Implant System
Version Model Number31142
Catalog Number31142
Company DUNS216693627
Company NameNeoss Ltd
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone999-999-9999
Emailcontact.usa@neoss.com
Phone999-999-9999
Emailcontact.usa@neoss.com
Phone999-999-9999
Emailcontact.usa@neoss.com
Phone999-999-9999
Emailcontact.usa@neoss.com
Phone999-999-9999
Emailcontact.usa@neoss.com
Phone999-999-9999
Emailcontact.usa@neoss.com
Phone999-999-9999
Emailcontact.usa@neoss.com
Phone999-999-9999
Emailcontact.usa@neoss.com
Phone999-999-9999
Emailcontact.usa@neoss.com
Phone999-999-9999
Emailcontact.usa@neoss.com
Phone999-999-9999
Emailcontact.usa@neoss.com
Phone999-999-9999
Emailcontact.usa@neoss.com
Phone999-999-9999
Emailcontact.usa@neoss.com
Phone999-999-9999
Emailcontact.usa@neoss.com
Phone999-999-9999
Emailcontact.usa@neoss.com
Phone999-999-9999
Emailcontact.usa@neoss.com
Phone999-999-9999
Emailcontact.usa@neoss.com
Phone999-999-9999
Emailcontact.usa@neoss.com
Phone999-999-9999
Emailcontact.usa@neoss.com
Phone999-999-9999
Emailcontact.usa@neoss.com
Phone999-999-9999
Emailcontact.usa@neoss.com
Phone999-999-9999
Emailcontact.usa@neoss.com
Phone999-999-9999
Emailcontact.usa@neoss.com
Phone999-999-9999
Emailcontact.usa@neoss.com
Phone999-999-9999
Emailcontact.usa@neoss.com
Phone999-999-9999
Emailcontact.usa@neoss.com
Phone999-999-9999
Emailcontact.usa@neoss.com
Phone999-999-9999
Emailcontact.usa@neoss.com
Phone999-999-9999
Emailcontact.usa@neoss.com
Phone999-999-9999
Emailcontact.usa@neoss.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105060440331015 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form
NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-05-22

On-Brand Devices [Neoss Implant System]

05060440333729Neoss ScanPost S (Ø3.25 TiBase)
05060440333712Neoss TiBase Ø3.25 (FX 3.4 S)
05060440333705Access Impression Coping 13 mm and Replica
05060440333699Access Abutment 6.0 mm
0506044033368251158 Drill – Sleeve Ø2.2 – 10 pcs
05060440333675Access Abutment 30° 4.9 mm
05060440333668Access Abutment 20° 4.6 mm
05060440333651Access Abutment 10° 4.6 mm
0506044033364431365 ScanPeg – 5 pcs
0506044033363731364 Esthetic Healing Abutment with ScanPeg - Molar
0506044033362031363 Esthetic Healing Abutment with ScanPeg - Pre-molar
0506044033361331362 Esthetic Healing Abutment with ScanPeg - Canine
0506044033360631361 Esthetic Healing Abutment with ScanPeg - Narrow Incisor
0506044033359031360 Esthetic Healing Abutment with ScanPeg - Wide Incisor
05060440333583Neoss iGO Screwdriver Machine 32mm
05060440333576Neoss iGO Screwdriver Machine 22mm
05060440333569Neoss iGO Laboratory Screw - 1 pc
05060440333552Neoss iGO Abutment Screw - 1 pc
0506044033354590232 Neoss Equator Cap Tool
0506044033352164034 Tack and Screw Cassette
0506044033341590231 Neoss Equator Cap Removal Tool
0506044033340890230 Neoss Equator Cap Insertion Tool
0506044033339290222 Neoss Equator Protector Disk - 10 pcs
0506044033338590220 Neoss Equator Impression Coping & Replica – 2 sets
0506044033337890214 Neoss Equator Cap Extra Soft Retention, Yellow – 2 pcs
0506044033336190213 Neoss Equator Cap Soft Retention, Pink – 2 pcs
0506044033335490212 Neoss Equator Cap Strong Retention, Violet – 2 pcs
0506044033334790211 Neoss Equator Cap Standard Retention, White – 2 pcs
0506044033333090210 Neoss Equator Cap and Housing Kit
0506044033332390145 Clix Deactivating Tool
0506044033331690144 Clix Activating Tool
0506044033330990143 Clix Gold Housing
0506044033329390142 Clix Insertion Tool
0506044033328690141 Clix Insert Kit
0506044033327990140 Clix Ti Housing kit
0506044033324890132 Neoss LOCATOR® Driver Machine, 23 mm
0506044033323190131 Neoss LOCATOR® Driver Manual, 15 mm
0506044033322490130 Neoss LOCATOR® core tool
0506044033321790122 Neoss LOCATOR® block out spacer, 20 pcs
0506044033320090120 Neoss LOCATOR® Impression Coping and Replica
0506044033319490115 Neoss LOCATOR® Replacement Male, Extra Light Retention, Extended Range, Red, 2 pcs
0506044033318790114 Neoss LOCATOR® Replacement Male, Standard Retention, Extended Range, Green, 2 pcs
0506044033317090113 Neoss LOCATOR® Replacement Male, Extra Light Retention, Blue, 2 pcs
0506044033316390112 Neoss LOCATOR® Replacement Male, Light Retention, Pink, 2 pcs
0506044033315690111 Neoss LOCATOR® Replacement Male, Standard Retention, Clear, 2 pcs
0506044033314990110 Neoss Locator® Male Processing Kit
0506044033313290107 Access LOCATOR® Abutment Kit, 0.5 mm
05060440333125Neoss LOCATOR® Abutment Kit 6 mm
05060440333118Neoss LOCATOR® Abutment Kit 5 mm
05060440333101Neoss LOCATOR® Abutment Kit 4 mm
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