| Primary Device ID | 00841549118524 |
| NIH Device Record Key | 81850962-9e20-468a-9bf8-8f1c79f8071a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | InstaGums® Soft Tissue Material |
| Version Model Number | 222025 |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00841549118524 [Primary] |
| EBI | Resin, Denture, Relining, Repairing, Rebasing |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-26 |
| Device Publish Date | 2023-07-18 |
| 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 |