ERA Implant® Countersink Drill, Micro
GUDID 00841549115004
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 Fixture/appliance dental drill bit, reusable Fixture/appliance dental drill bit, reusable Fixture/appliance dental drill bit, reusable| Primary Device ID | 00841549115004 |
| NIH Device Record Key | f7892074-78be-4d01-8e70-6c8cb8c2694f |
| Commercial Distribution Discontinuation | 2023-10-06 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | ERA Implant® Countersink Drill, Micro |
| Version Model Number | 905517 |
| 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 | 508-226-5660 |
| laura.greige@sterngold.com | |
| Phone | 508-226-5660 |
| laura.greige@sterngold.com | |
| Phone | 508-226-5660 |
| laura.greige@sterngold.com | |
| Phone | 508-226-5660 |
| laura.greige@sterngold.com | |
| Phone | 508-226-5660 |
| laura.greige@sterngold.com | |
| Phone | 508-226-5660 |
| laura.greige@sterngold.com | |
| Phone | 508-226-5660 |
| laura.greige@sterngold.com | |
| Phone | 508-226-5660 |
| laura.greige@sterngold.com | |
| Phone | 508-226-5660 |
| laura.greige@sterngold.com | |
| Phone | 508-226-5660 |
| laura.greige@sterngold.com | |
| Phone | 508-226-5660 |
| laura.greige@sterngold.com | |
| Phone | 508-226-5660 |
| laura.greige@sterngold.com | |
| Phone | 508-226-5660 |
| laura.greige@sterngold.com | |
| Phone | 508-226-5660 |
| laura.greige@sterngold.com | |
| Phone | 508-226-5660 |
| laura.greige@sterngold.com | |
| Phone | 508-226-5660 |
| laura.greige@sterngold.com | |
| Phone | 508-226-5660 |
| laura.greige@sterngold.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841549115004 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K041271
FDA Product Code
| DZI | Drill, Bone, Powered |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00841549115004]
Moist Heat or Steam Sterilization
[00841549115004]
Moist Heat or Steam Sterilization
[00841549115004]
Moist Heat or Steam Sterilization
[00841549115004]
Moist Heat or Steam Sterilization
[00841549115004]
Moist Heat or Steam Sterilization
[00841549115004]
Moist Heat or Steam Sterilization
[00841549115004]
Moist Heat or Steam Sterilization
[00841549115004]
Moist Heat or Steam Sterilization
[00841549115004]
Moist Heat or Steam Sterilization
[00841549115004]
Moist Heat or Steam Sterilization
[00841549115004]
Moist Heat or Steam Sterilization
[00841549115004]
Moist Heat or Steam Sterilization
[00841549115004]
Moist Heat or Steam Sterilization
[00841549115004]
Moist Heat or Steam Sterilization
[00841549115004]
Moist Heat or Steam Sterilization
[00841549115004]
Moist Heat or Steam Sterilization
[00841549115004]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-10-09 |
| Device Publish Date | 2020-06-01 |
Devices Manufactured by STERNGOLD DENTAL LLC
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| 00841549119170 - MOR | 2024-04-22 Comfort Cap 4 pack |
| 00841549118289 - Platinum Foil 1 DWT | 2023-10-16 92mm x 32mm x .02 mm thick |
| 00841549108280 - MOR®-A Implant | 2023-10-13 3.0 x 10mm, Ti |
| 00841549108297 - MOR®-A Implant | 2023-10-13 3.0 x 13mm, Ti |
| 00841549108303 - MOR®-A Implant | 2023-10-13 3.0 x 15mm, Ti |
| 00841549108310 - MOR®-A Implant | 2023-10-13 3.0 x 18mm, Ti |
| 00841549115707 - TRU®/PUR® Surgical Kit | 2023-10-13 |
Trademark Results [ERA Implant]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ERA IMPLANT 78716101 3372893 Live/Registered |
STERNGOLD DENTAL LLC 2005-09-19 |
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