Stern EX Surgical Kit Complete

GUDID 00841549114533

The Stern IC Surgical Kit consists of various surgical tools such as drills, countersinks, bone taps, insertion tools and torque wrenches. Intended to be used during implant surgical procedure to drill, bone tap or countersink bone or tissue in the mandible or maxilla of patient. It consists of surgical tools needed for the implant surgical procedure.

STERNGOLD DENTAL LLC

Dental/maxillofacial surgical procedure kit, medicated, reusable Dental/maxillofacial surgical procedure kit, medicated, reusable Dental/maxillofacial surgical procedure kit, medicated, reusable Dental/maxillofacial surgical procedure kit, medicated, reusable Dental/maxillofacial surgical procedure kit, medicated, reusable Dental/maxillofacial surgical procedure kit, medicated, reusable Dental/maxillofacial surgical procedure kit, medicated, reusable Dental/maxillofacial surgical procedure kit, medicated, reusable
Primary Device ID00841549114533
NIH Device Record Keyad4cf0c4-e69e-495d-a6a1-0f565dc3a755
Commercial Distribution Discontinuation2021-08-09
Commercial Distribution StatusNot in Commercial Distribution
Brand NameStern EX Surgical Kit Complete
Version Model Number905129
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 Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100841549114533 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZIDrill, Bone, Powered

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841549114533]

Moist Heat or Steam Sterilization


[00841549114533]

Moist Heat or Steam Sterilization


[00841549114533]

Moist Heat or Steam Sterilization


[00841549114533]

Moist Heat or Steam Sterilization


[00841549114533]

Moist Heat or Steam Sterilization


[00841549114533]

Moist Heat or Steam Sterilization


[00841549114533]

Moist Heat or Steam Sterilization


[00841549114533]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-08-10
Device Publish Date2020-06-01

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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