Stern EX Acid Etched Implant Ti RP 4.0x15.0mm, Biomain

GUDID 00841549109270

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

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Primary Device ID00841549109270
NIH Device Record Key506e0259-0774-43e1-8f4d-f39ee287741f
Commercial Distribution StatusIn Commercial Distribution
Brand NameStern EX Acid Etched Implant Ti RP 4.0x15.0mm, Biomain
Version Model Number901846
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

Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841549109270 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-08
Device Publish Date2020-05-29

Devices Manufactured by STERNGOLD DENTAL LLC

00841549119187 - Stern Snap One Piece Abutment 1mm Cuff (BK)2024-07-02 The SternSnap Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the t
00841549119194 - Stern Snap One Piece Abutment 2mm Cuff (BK)2024-07-02 The SternSnap Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the t
00841549119200 - Stern Snap One Piece Abutment 3mm Cuff (BK)2024-07-02 The SternSnap Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the t
00841549119217 - Stern Snap One Piece Abutment 4mm Cuff (BK)2024-07-02 The SternSnap Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the t
00841549119224 - Stern Snap One Piece Abutment 5mm Cuff (BK)2024-07-02 The SternSnap Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the t
00841549119231 - Stern Snap Abutment Base 2.4mm (BK)2024-07-02 Intended for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or tota
00841549119248 - Stern Snap Abutment Base 3.0mm (BK)2024-07-02 Intended for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or tota
00841549119255 - Stern Snap Abutment Base 4.0mm (BK)2024-07-02 Intended for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or tota

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