Stern IC Acid Etched Implant 3.3mm RN, 1.8mm collar, 12mm, Ti

GUDID 08415491062895

The Stern IC Dental Implant device is a root-form dental implant with a screw-type body, acid etched except for the neck of the implant, which is machined to a smooth finish. It is manufactured from pure grade 4 titanium with a flared neck, used for one-stage, transgingival or subgingival implantation. The neck and body include an internal taper and octagon. The implants are composed of grade 4 commercially pure titanium and are available in a range of lengths and diameters.The Stern IC Dental implant System is intended for long term surgical implantation in the bone of the patient’s upper or lower arch to provide immediate load or delayed load of prosthetic systems, such as artificial teeth, in order to restore the patient’s chewing function. It is also indicated for immediate loading with good primary stability and appropriate occlusal loading.

STERNGOLD DENTAL LLC

Dental implant suprastructure, permanent, preformed
Primary Device ID08415491062895
NIH Device Record Key7f8f71b2-ddce-40cc-8ee8-7dc9df0c1788
Commercial Distribution StatusIn Commercial Distribution
Brand NameStern IC Acid Etched Implant 3.3mm RN, 1.8mm collar, 12mm, Ti
Version Model Number902727
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@sterngold.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108415491062895 [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 Date2016-03-09

On-Brand Devices [Stern IC Acid Etched Implant 3.3mm RN, 1.8mm collar, 12mm, Ti]

08415491062895The Stern IC Dental Implant device is a root-form dental implant with a screw-type body, acid et
00841549109973The Stern IC Dental Implant device is a root-form dental implant with a screw-type body, acid et

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