Sterngold Implant System Dense Bone Drill 3.25mm

GUDID 00841549114892

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

Primary Device ID	00841549114892
NIH Device Record Key	5206e28b-1139-4401-832c-fa98c7dabc92
Commercial Distribution Status	In Commercial Distribution
Brand Name	Sterngold Implant System Dense Bone Drill 3.25mm
Version Model Number	905336
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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841549114892 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K902158

FDA Product Code

DZE	Implant, Endosseous, Root-Form