G-Stop Keys-Large-3mm

GUDID 00850017652385

Provides vertical control for drilling the osteotomy. The G-Stop Gauges and G-Stop Keys can be used with printed guides to control the angulation of the hole

VERSAH, LLC

Dental implant system

• Primary Device ID: 00850017652385
• NIH Device Record Key: 83c5550d-a461-4e1f-b624-bd1d795b8e4c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: G-Stop Keys-Large-3mm
• Version Model Number: VTSP-L-O-3
• Company DUNS: 081472844
• Company Name: VERSAH, 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: true
• 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: 844-711-5585
• Email: info@versah.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850017652385 [Primary]

FDA Product Code

• EJL: Bur, Dental

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-27
• Device Publish Date: 2020-04-17

Devices Manufactured by VERSAH, LLC

• 00850017652798 - Densah® Bur G3: 2023-09-27 4.5mm-4.5mm Densah® Bur G3 33mm length
• 00850017652804 - Densah® Bur G3: 2023-09-27 4.8mm-5.8mm Densah® Bur G3 33mm length
• 00850017652811 - Densah® Bur G3: 2023-09-27 5.5mm-6.5mm Densah® Bur G3
• 00850017652828 - Densah® Bur G3: 2023-09-27 5.5mm-6.8mm Densah® Bur G3
• 00850017652606 - 1.5mm-2.5mm ZGO Densah Bur 55mm length: 2022-07-07 ZGO Densah Burs are indicated for use to prepare osteotomies for implant placement in maxilla (including the zygoma and ptergoid
• 00850017652613 - 1.5mm-2.5mm ZGO Densah Bur 65mm length: 2022-07-07 ZGO Densah Burs are indicated for use to prepare osteotomies for implant placement in maxilla (including the zygoma and ptergoid
• 00850017652620 - 1.5mm-2.5mm ZGO Densah Bur 90mm length: 2022-07-07 ZGO Densah Burs are indicated for use to prepare osteotomies for implant placement in maxilla (including the zygoma and ptergoid
• 00850017652637 - 2.0mm-3.0mm ZGO Densah Bur 55mm length: 2022-07-07 ZGO Densah Burs are indicated for use to prepare osteotomies for implant placement in maxilla (including the zygoma and ptergoid