Stern EX Acid Etched Implant RP 3.75x13.0mm, Direct Delivery, Ti

GUDID 00841549108846

The Sterngold Acid Etch Dental Implant System consists of standard, external-hex, self-tapping, doublethreaded, root-form endosseous implants that will be available is a variety of sizes to suit individual usedpatient needs. Each implant is provided with a cover screw. The implants are manufactured from pure, implant-grade titanium. The external surface of the implants (excluding the top three threads, the neck and the implant head) is lightly acid etched to remove any traces of contaminants remaining from the manufacturing process, and to achieve a slightly roughened microsurface to aid in implant osseointegration. The proposed implants are compatible with standard, regular platform (4. lmm), external-hex (antirotational) abutments such as the currently marketed Sterngold-ImplaMed, Implant Innovations, and Branemark System (Nobel Biocare). A specially-designed SternTwist internal grip insertion tool will be available as an accessory to the Acid Etch Implants. Intended for implantation into any area of the fully endentulous maxilla and mandible for the support of a removable or fixed dental prosthesis For implantation into any area of the partially endentulous maxilla and mandible for the support of a removable or fixed dental prosthesis For single tooth or multiple unit prosthesis.

STERNGOLD DENTAL LLC

Dental implant suprastructure, permanent, preformed
Primary Device ID00841549108846
NIH Device Record Key40190d09-9c8a-4c5f-9844-d48897c7153a
Commercial Distribution Discontinuation2019-12-20
Commercial Distribution StatusNot in Commercial Distribution
Brand NameStern EX Acid Etched Implant RP 3.75x13.0mm, Direct Delivery, Ti
Version Model Number901643
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
GS100841549108846 [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 Number6
Public Version Date2020-05-22
Device Publish Date2016-03-23

On-Brand Devices [Stern EX Acid Etched Implant RP 3.75x13.0mm, Direct Delivery, Ti]

08415491054869The Sterngold Acid Etch Dental Implant System consists of standard, external-hex, self-tapping,
00841549108846The Sterngold Acid Etch Dental Implant System consists of standard, external-hex, self-tapping,

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