ERA Implant® 3.25 Bone Tap 10, 13, 15mm
GUDID 00841549115035
A metal device intended to be used to create internal threads in surgical site for implants. They are available in narrow and regular platforms and different sizes.
STERNGOLD DENTAL LLC
Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable| Primary Device ID | 00841549115035 |
| NIH Device Record Key | 9185c435-f2f5-45c6-b076-05fe9a7bfa00 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ERA Implant® 3.25 Bone Tap 10, 13, 15mm |
| Version Model Number | 905521 |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841549115035 [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 |
[00841549115035]
Moist Heat or Steam Sterilization
[00841549115035]
Moist Heat or Steam Sterilization
[00841549115035]
Moist Heat or Steam Sterilization
[00841549115035]
Moist Heat or Steam Sterilization
[00841549115035]
Moist Heat or Steam Sterilization
[00841549115035]
Moist Heat or Steam Sterilization
[00841549115035]
Moist Heat or Steam Sterilization
[00841549115035]
Moist Heat or Steam Sterilization
[00841549115035]
Moist Heat or Steam Sterilization
[00841549115035]
Moist Heat or Steam Sterilization
[00841549115035]
Moist Heat or Steam Sterilization
[00841549115035]
Moist Heat or Steam Sterilization
[00841549115035]
Moist Heat or Steam Sterilization
[00841549115035]
Moist Heat or Steam Sterilization
[00841549115035]
Moist Heat or Steam Sterilization
[00841549115035]
Moist Heat or Steam Sterilization
[00841549115035]
Moist Heat or Steam Sterilization
[00841549115035]
Moist Heat or Steam Sterilization
[00841549115035]
Moist Heat or Steam Sterilization
[00841549115035]
Moist Heat or Steam Sterilization
[00841549115035]
Moist Heat or Steam Sterilization
[00841549115035]
Moist Heat or Steam Sterilization
[00841549115035]
Moist Heat or Steam Sterilization
[00841549115035]
Moist Heat or Steam Sterilization
[00841549115035]
Moist Heat or Steam Sterilization
[00841549115035]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-01-09 |
| Device Publish Date | 2017-06-27 |
Devices Manufactured by STERNGOLD DENTAL LLC
| 00841549119163 - MOR | 2024-04-22 Comfort Cap 10 pack |
| 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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