| Primary Device ID | 00841549100475 |
| NIH Device Record Key | 3269aff1-f8b4-42e4-a613-0bbcb2877f0a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TempoLok NE Cement 118g cartridge, 50 mixing tips |
| Version Model Number | 220282 |
| 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 | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841549100475 [Primary] |
| EMA | Cement, Dental |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-01-09 |
| Device Publish Date | 2017-02-24 |
| 00841549115851 - Master | 2024-12-05 Master Endo Post Starter Kit |
| 00841549115868 - Lab | 2024-12-05 Lab Burnout Post Starter Kit |
| 00841549115875 - Hader | 2024-12-05 Hader Vertical Starter Kit |
| 00841549115882 - Hader | 2024-12-05 Hader Vertical Males Only, 6 |
| 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 |