ERA® Direct Ovd. Gutta Percha Drill

GUDID 00841549102035

A metal device 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. There are depth marks along the length of some drills corresponding to the different size implant bodies. These marks are laser etched. Some drills are marked with the diameter in millimeters on the shank. Intended to be used to generate the bore into the bone into which an implant body or attachment is installed into.

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 Steel dental bur, reusable Steel dental bur, reusable Steel dental bur, reusable Steel dental bur, reusable Steel dental bur, reusable Steel dental bur, reusable Steel dental bur, reusable Steel dental bur, reusable Steel dental bur, reusable Steel dental bur, reusable Steel dental bur, reusable Steel dental bur, reusable Steel dental bur, reusable Steel dental bur, reusable Steel dental bur, reusable Steel dental bur, reusable Steel dental bur, reusable Steel dental bur, reusable

• Primary Device ID: 00841549102035
• NIH Device Record Key: 55134327-90c9-47e5-b03b-7b7aaf18556d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ERA® Direct Ovd. Gutta Percha Drill
• Version Model Number: 811440
• 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: 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: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com
• Phone: 5082265660
• Email: laura.greige@sterngold.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841549102035 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K902158

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

[00841549102035]

Moist Heat or Steam Sterilization

[00841549102035]

Moist Heat or Steam Sterilization

[00841549102035]

Moist Heat or Steam Sterilization

[00841549102035]

Moist Heat or Steam Sterilization

[00841549102035]

Moist Heat or Steam Sterilization

[00841549102035]

Moist Heat or Steam Sterilization

[00841549102035]

Moist Heat or Steam Sterilization

[00841549102035]

Moist Heat or Steam Sterilization

[00841549102035]

Moist Heat or Steam Sterilization

[00841549102035]

Moist Heat or Steam Sterilization

[00841549102035]

Moist Heat or Steam Sterilization

[00841549102035]

Moist Heat or Steam Sterilization

[00841549102035]

Moist Heat or Steam Sterilization

[00841549102035]

Moist Heat or Steam Sterilization

[00841549102035]

Moist Heat or Steam Sterilization

[00841549102035]

Moist Heat or Steam Sterilization

[00841549102035]

Moist Heat or Steam Sterilization

[00841549102035]

Moist Heat or Steam Sterilization

[00841549102035]

Moist Heat or Steam Sterilization

[00841549102035]

Moist Heat or Steam Sterilization

[00841549102035]

Moist Heat or Steam Sterilization

[00841549102035]

Moist Heat or Steam Sterilization

[00841549102035]

Moist Heat or Steam Sterilization

[00841549102035]

Moist Heat or Steam Sterilization

[00841549102035]

Moist Heat or Steam Sterilization

[00841549102035]

Moist Heat or Steam Sterilization

[00841549102035]

Moist Heat or Steam Sterilization

[00841549102035]

Moist Heat or Steam Sterilization

[00841549102035]

Moist Heat or Steam Sterilization

[00841549102035]

Moist Heat or Steam Sterilization

[00841549102035]

Moist Heat or Steam Sterilization

[00841549102035]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-10
• Device Publish Date: 2020-07-02

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