Sterngold Implant System

GUDID 00841549118654

Guided Drill 2.0mm x 12mm

STERNGOLD DENTAL LLC

Fixture/appliance dental drill bit, reusable Fixture/appliance dental drill bit, reusable Fixture/appliance dental drill bit, reusable Fixture/appliance dental drill bit, reusable Fixture/appliance dental drill bit, reusable Fixture/appliance dental drill bit, reusable Fixture/appliance dental drill bit, reusable Fixture/appliance dental drill bit, reusable Fixture/appliance dental drill bit, reusable Fixture/appliance dental drill bit, reusable Fixture/appliance dental drill bit, reusable Fixture/appliance dental drill bit, reusable Fixture/appliance dental drill bit, reusable Fixture/appliance dental drill bit, reusable Fixture/appliance dental drill bit, reusable Fixture/appliance dental drill bit, reusable Fixture/appliance dental drill bit, reusable
Primary Device ID00841549118654
NIH Device Record Key121ab1ad-d32c-4c91-ad05-5cc63c3b65ae
Commercial Distribution StatusIn Commercial Distribution
Brand NameSterngold Implant System
Version Model Number905761
Company DUNS124763728
Company NameSTERNGOLD DENTAL LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100841549118654 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841549118654]

Moist Heat or Steam Sterilization

[00841549118654]

Moist Heat or Steam Sterilization

[00841549118654]

Moist Heat or Steam Sterilization

[00841549118654]

Moist Heat or Steam Sterilization

[00841549118654]

Moist Heat or Steam Sterilization

[00841549118654]

Moist Heat or Steam Sterilization

[00841549118654]

Moist Heat or Steam Sterilization

[00841549118654]

Moist Heat or Steam Sterilization

[00841549118654]

Moist Heat or Steam Sterilization

[00841549118654]

Moist Heat or Steam Sterilization

[00841549118654]

Moist Heat or Steam Sterilization

[00841549118654]

Moist Heat or Steam Sterilization

[00841549118654]

Moist Heat or Steam Sterilization

[00841549118654]

Moist Heat or Steam Sterilization

[00841549118654]

Moist Heat or Steam Sterilization

[00841549118654]

Moist Heat or Steam Sterilization

[00841549118654]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-13
Device Publish Date2023-10-05

On-Brand Devices [Sterngold Implant System]

00841549119088Guided Surgery Kit (no tools)
00841549119057Guided Surgery Kit
00841549119040Bone Mill Guide Pin - TRU RP
00841549119033Bone Mill Guide Pin - TRU NP
00841549119026Bone Mill Guide Pin - PUR RP
00841549119019Bone Mill Guide Pin - PUR NP
00841549119002Bone Mill
00841549118999Square to Latch Adapter
00841549118982Guided Latch Driver - TRU NP
00841549118975Guided Latch Driver - TRU RP
00841549118968Guided Latch Driver - PUR
00841549118951Guided Tap 5.0
00841549118944Guided Tap 4.3
00841549118937Guided Tap 3.5
00841549118920Guided Tap 3.2
00841549118913Guided Crestal Bone Drill 5.0
00841549118906Guided Crestal Bone Drill 4.3
00841549118890Guided Crestal Bone Drill 3.5
00841549118883Guided Crestal Bone Drill 3.2
00841549118876Guided Flat Drill
00841549118869Guided Drill 4.75mm x 14mm
00841549118852Guided Drill 4.75mm x 12mm
00841549118845Guided Drill 4.75mm x 10mm
00841549118838Guided Drill 4.75mm x 8mm
00841549118821Guided Drill 4.75mm x 6mm
00841549118814Guided Drill 4.05mm x 14mm
00841549118807Guided Drill 4.05mm x 12mm
00841549118791Guided Drill 4.05mm x 10mm
00841549118784Guided Drill 4.05mm x 8mm
00841549118777Guided Drill 4.05mm x 6mm
00841549118760Guided Drill 3.25mm x 14mm
00841549118753Guided Drill 3.25mm x 12mm
00841549118746Guided Drill 3.25mm x 10mm
00841549118739Guided Drill 3.25mm x 8mm
00841549118722Guided Drill 3.25mm x 6mm
00841549118715Guided Drill 2.7mm x 14mm
00841549118708Guided Drill 2.7mm x 12mm
00841549118692Guided Drill 2.7mm x 10mm
00841549118685Guided Drill 2.7mm x 8mm
00841549118678Guided Drill 2.7mm x 6mm
00841549118661Guided Drill 2.0mm x 14mm
00841549118647Guided Drill 2.0mm x 10mm
00841549118630Guided Drill 2.0mm x 8mm
00841549118258Guided Drill 2.0mm x 6mm
00841549118623Guided Mount Screw - TRU NP
00841549118616Guided Mount - TRU NP
00841549118609Guided Wrench Driver - TRU NP
00841549118593Guided Wrench Driver - TRU RP
00841549118586Guided Mount Screw - TRU RP
00841549118579Guided Mount - TRU RP
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.