PUR NP Implant 3.5 x 10mm, Ti

GUDID 08415491155177

The PUR is a self-tapping, double thread screw implant with a micro groove section, manufactured from Wrought Titanium 6AL-4V ELI. The implant surface is acid etched. The implants are manufactured with four body diameters 3.5 mm, 4.3 mm, 5.0 mm, and 6.0 mm. The 3.5 and 4.3 mm implants have a Narrow Platform (NP) prosthetic head. The 5.0 and 6.0 mm implants have a Regular Platform (RP) prosthetic head. The PUR Implant System can be used in dental implant applications, for oral reha¬bilitation of edentulous and partially dentate patients in the maxilla and mandible. Implant retained restorations may consist of single crowns or bridges as well as complete or partial dentures. The PUR Implant is intended for delayed loading. It is also indicated for immediate loading with good primary stability and appropriate occlusal loading. The PUR Implant System is only intended for use with straight abutments. The PUR implant body is intended to be placed such no angle correction is necessary.

STERNGOLD DENTAL LLC

Dental implant suprastructure, permanent, preformed
Primary Device ID08415491155177
NIH Device Record Key0c9a78b8-2472-4d91-ab61-1224fba96bed
Commercial Distribution StatusIn Commercial Distribution
Brand NamePUR NP Implant 3.5 x 10mm, Ti
Version Model Number901357
Company DUNS124763728
Company NameSTERNGOLD DENTAL LLC
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

Phone401-871-3489
Emailmaria.rao@stermgold.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108415491155177 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-08
Device Publish Date2016-03-01

On-Brand Devices [PUR NP Implant 3.5 x 10mm, Ti]

08415491155177The PUR is a self-tapping, double thread screw implant with a micro groove section, manufactured
00841549107399The PUR is a self-tapping, double thread screw implant with a micro groove section, manufactured

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