MOR Twist Drill, 1.2mm

GUDID 00841549114755

A sterile shaft of metal (a drill bit) intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. It is typically made of a highgrade stainless steel alloy. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a motorized handpiece or other power source that provides rotation. This is a single use device that is intended, in terms of sterility, for a single patient use.

STERNGOLD DENTAL LLC

Fixture/appliance dental drill bit, single-use

• Primary Device ID: 00841549114755
• NIH Device Record Key: 957b4df4-0797-420a-bdeb-a05e628cd8ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MOR Twist Drill, 1.2mm
• Version Model Number: 905268
• Company DUNS: 124763728
• Company Name: STERNGOLD DENTAL LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841549114755 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153173

FDA Product Code

• DZA: Drill, Dental, Intraoral

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-01-09
• Device Publish Date: 2016-03-10

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