Sterngold Implant System

GUDID 00841549118654

Guided Drill 2.0mm x 12mm

STERNGOLD DENTAL LLC

Fixture/appliance dental drill bit, reusable

• Primary Device ID: 00841549118654
• NIH Device Record Key: 121ab1ad-d32c-4c91-ad05-5cc63c3b65ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sterngold Implant System
• Version Model Number: 905761
• Company DUNS: 124763728
• Company Name: STERNGOLD DENTAL LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 401-871-3489
• Email: maria.rao@sterngold.com
• Phone: 401-871-3489
• Email: maria.rao@sterngold.com
• Phone: 401-871-3489
• Email: maria.rao@sterngold.com
• Phone: 401-871-3489
• Email: maria.rao@sterngold.com
• Phone: 401-871-3489
• Email: maria.rao@sterngold.com
• Phone: 401-871-3489
• Email: maria.rao@sterngold.com
• Phone: 401-871-3489
• Email: maria.rao@sterngold.com
• Phone: 401-871-3489
• Email: maria.rao@sterngold.com
• Phone: 401-871-3489
• Email: maria.rao@sterngold.com
• Phone: 401-871-3489
• Email: maria.rao@sterngold.com
• Phone: 401-871-3489
• Email: maria.rao@sterngold.com
• Phone: 401-871-3489
• Email: maria.rao@sterngold.com
• Phone: 401-871-3489
• Email: maria.rao@sterngold.com
• Phone: 401-871-3489
• Email: maria.rao@sterngold.com
• Phone: 401-871-3489
• Email: maria.rao@sterngold.com
• Phone: 401-871-3489
• Email: maria.rao@sterngold.com
• Phone: 401-871-3489
• Email: maria.rao@sterngold.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841549118654 [Primary]

FDA Product Code

• NDP: Accessories, Implant, Dental, Endosseous

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[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 Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-13
• Device Publish Date: 2023-10-05

On-Brand Devices [Sterngold Implant System]

• 00841549119088: Guided Surgery Kit (no tools)
• 00841549119057: Guided Surgery Kit
• 00841549119040: Bone Mill Guide Pin - TRU RP
• 00841549119033: Bone Mill Guide Pin - TRU NP
• 00841549119026: Bone Mill Guide Pin - PUR RP
• 00841549119019: Bone Mill Guide Pin - PUR NP
• 00841549119002: Bone Mill
• 00841549118999: Square to Latch Adapter
• 00841549118982: Guided Latch Driver - TRU NP
• 00841549118975: Guided Latch Driver - TRU RP
• 00841549118968: Guided Latch Driver - PUR
• 00841549118951: Guided Tap 5.0
• 00841549118944: Guided Tap 4.3
• 00841549118937: Guided Tap 3.5
• 00841549118920: Guided Tap 3.2
• 00841549118913: Guided Crestal Bone Drill 5.0
• 00841549118906: Guided Crestal Bone Drill 4.3
• 00841549118890: Guided Crestal Bone Drill 3.5
• 00841549118883: Guided Crestal Bone Drill 3.2
• 00841549118876: Guided Flat Drill
• 00841549118869: Guided Drill 4.75mm x 14mm
• 00841549118852: Guided Drill 4.75mm x 12mm
• 00841549118845: Guided Drill 4.75mm x 10mm
• 00841549118838: Guided Drill 4.75mm x 8mm
• 00841549118821: Guided Drill 4.75mm x 6mm
• 00841549118814: Guided Drill 4.05mm x 14mm
• 00841549118807: Guided Drill 4.05mm x 12mm
• 00841549118791: Guided Drill 4.05mm x 10mm
• 00841549118784: Guided Drill 4.05mm x 8mm
• 00841549118777: Guided Drill 4.05mm x 6mm
• 00841549118760: Guided Drill 3.25mm x 14mm
• 00841549118753: Guided Drill 3.25mm x 12mm
• 00841549118746: Guided Drill 3.25mm x 10mm
• 00841549118739: Guided Drill 3.25mm x 8mm
• 00841549118722: Guided Drill 3.25mm x 6mm
• 00841549118715: Guided Drill 2.7mm x 14mm
• 00841549118708: Guided Drill 2.7mm x 12mm
• 00841549118692: Guided Drill 2.7mm x 10mm
• 00841549118685: Guided Drill 2.7mm x 8mm
• 00841549118678: Guided Drill 2.7mm x 6mm
• 00841549118661: Guided Drill 2.0mm x 14mm
• 00841549118647: Guided Drill 2.0mm x 10mm
• 00841549118630: Guided Drill 2.0mm x 8mm
• 00841549118258: Guided Drill 2.0mm x 6mm
• 00841549118623: Guided Mount Screw - TRU NP
• 00841549118616: Guided Mount - TRU NP
• 00841549118609: Guided Wrench Driver - TRU NP
• 00841549118593: Guided Wrench Driver - TRU RP
• 00841549118586: Guided Mount Screw - TRU RP
• 00841549118579: Guided Mount - TRU RP