ERA Implant® Surgical Kit, Complete
GUDID 00841549114526
The ERA Implant Surgical Kit consists of various surgical tools such as drills, countersinks, bone taps, insertion tools and torque wrenches. Intended to be used during implant surgical procedure to drill, bone tap or countersink bone or tissue in the mandible or maxilla of patient. It consists of surgical tools needed for the implant surgical procedure.
STERNGOLD DENTAL LLC
Dental/maxillofacial surgical procedure kit, medicated, reusable Dental/maxillofacial surgical procedure kit, medicated, reusable Dental/maxillofacial surgical procedure kit, medicated, reusable Dental/maxillofacial surgical procedure kit, medicated, reusable Dental/maxillofacial surgical procedure kit, medicated, reusable Dental/maxillofacial surgical procedure kit, medicated, reusable Dental/maxillofacial surgical procedure kit, medicated, reusable Dental/maxillofacial surgical procedure kit, medicated, reusable Dental/maxillofacial surgical procedure kit, medicated, reusable Dental/maxillofacial surgical procedure kit, medicated, reusable Dental/maxillofacial surgical procedure kit, medicated, reusable Dental/maxillofacial surgical procedure kit, medicated, reusable Dental/maxillofacial surgical procedure kit, medicated, reusable Dental/maxillofacial surgical procedure kit, medicated, reusable Dental/maxillofacial surgical procedure kit, medicated, reusable Dental/maxillofacial surgical procedure kit, medicated, reusable Dental/maxillofacial surgical procedure kit, medicated, reusable Dental/maxillofacial surgical procedure kit, medicated, reusable Dental/maxillofacial surgical procedure kit, medicated, reusable Dental/maxillofacial surgical procedure kit, medicated, reusable Dental/maxillofacial surgical procedure kit, medicated, reusable Dental/maxillofacial surgical procedure kit, medicated, reusable Dental/maxillofacial surgical procedure kit, medicated, reusable Dental/maxillofacial surgical procedure kit, medicated, reusable Dental/maxillofacial surgical procedure kit, medicated, reusable Dental/maxillofacial surgical procedure kit, medicated, reusable Dental/maxillofacial surgical procedure kit, medicated, reusable Dental/maxillofacial surgical procedure kit, medicated, reusable| Primary Device ID | 00841549114526 |
| NIH Device Record Key | 8e349f9e-346d-4a53-bb80-6797645be789 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ERA Implant® Surgical Kit, Complete |
| Version Model Number | 905119 |
| 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 | true |
| 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 | 00841549114526 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K041271
FDA Product Code
| DZE | Implant, Endosseous, Root-Form |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00841549114526]
Moist Heat or Steam Sterilization
[00841549114526]
Moist Heat or Steam Sterilization
[00841549114526]
Moist Heat or Steam Sterilization
[00841549114526]
Moist Heat or Steam Sterilization
[00841549114526]
Moist Heat or Steam Sterilization
[00841549114526]
Moist Heat or Steam Sterilization
[00841549114526]
Moist Heat or Steam Sterilization
[00841549114526]
Moist Heat or Steam Sterilization
[00841549114526]
Moist Heat or Steam Sterilization
[00841549114526]
Moist Heat or Steam Sterilization
[00841549114526]
Moist Heat or Steam Sterilization
[00841549114526]
Moist Heat or Steam Sterilization
[00841549114526]
Moist Heat or Steam Sterilization
[00841549114526]
Moist Heat or Steam Sterilization
[00841549114526]
Moist Heat or Steam Sterilization
[00841549114526]
Moist Heat or Steam Sterilization
[00841549114526]
Moist Heat or Steam Sterilization
[00841549114526]
Moist Heat or Steam Sterilization
[00841549114526]
Moist Heat or Steam Sterilization
[00841549114526]
Moist Heat or Steam Sterilization
[00841549114526]
Moist Heat or Steam Sterilization
[00841549114526]
Moist Heat or Steam Sterilization
[00841549114526]
Moist Heat or Steam Sterilization
[00841549114526]
Moist Heat or Steam Sterilization
[00841549114526]
Moist Heat or Steam Sterilization
[00841549114526]
Moist Heat or Steam Sterilization
[00841549114526]
Moist Heat or Steam Sterilization
[00841549114526]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-07-15 |
| Device Publish Date | 2020-07-07 |
Devices Manufactured by STERNGOLD DENTAL LLC
| 00841549119187 - Stern Snap One Piece Abutment 1mm Cuff (BK) | 2024-07-02 The SternSnap Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the t |
| 00841549119194 - Stern Snap One Piece Abutment 2mm Cuff (BK) | 2024-07-02 The SternSnap Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the t |
| 00841549119200 - Stern Snap One Piece Abutment 3mm Cuff (BK) | 2024-07-02 The SternSnap Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the t |
| 00841549119217 - Stern Snap One Piece Abutment 4mm Cuff (BK) | 2024-07-02 The SternSnap Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the t |
| 00841549119224 - Stern Snap One Piece Abutment 5mm Cuff (BK) | 2024-07-02 The SternSnap Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the t |
| 00841549119231 - Stern Snap Abutment Base 2.4mm (BK) | 2024-07-02 Intended for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or tota |
| 00841549119248 - Stern Snap Abutment Base 3.0mm (BK) | 2024-07-02 Intended for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or tota |
| 00841549119255 - Stern Snap Abutment Base 4.0mm (BK) | 2024-07-02 Intended for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or tota |
Trademark Results [ERA Implant]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ERA IMPLANT 78716101 3372893 Live/Registered |
STERNGOLD DENTAL LLC 2005-09-19 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.