| Primary Device ID | 00766054002826 |
| NIH Device Record Key | ef8c7370-e217-4602-846a-a3dd8c0bce64 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Safesider HF |
| Version Model Number | 5104-G25 |
| Catalog Number | 5104-G25 |
| Company DUNS | 101147171 |
| Company Name | ESSENTIAL DENTAL SYSTEMS, INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| 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 | false |
| 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 | +1(201)487-9090 |
| udi@edsdental.com | |
| Phone | +1(201)487-9090 |
| udi@edsdental.com | |
| Phone | +1(201)487-9090 |
| udi@edsdental.com | |
| Phone | +1(201)487-9090 |
| udi@edsdental.com | |
| Phone | +1(201)487-9090 |
| udi@edsdental.com | |
| Phone | +1(201)487-9090 |
| udi@edsdental.com | |
| Phone | +1(201)487-9090 |
| udi@edsdental.com | |
| Phone | +1(201)487-9090 |
| udi@edsdental.com | |
| Phone | +1(201)487-9090 |
| udi@edsdental.com | |
| Phone | +1(201)487-9090 |
| udi@edsdental.com | |
| Phone | +1(201)487-9090 |
| udi@edsdental.com | |
| Phone | +1(201)487-9090 |
| udi@edsdental.com | |
| Phone | +1(201)487-9090 |
| udi@edsdental.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00766054002826 [Primary] |
| EKM | GUTTA-PERCHA |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-07-27 |
| Device Publish Date | 2020-07-17 |
| 00766054002833 | SafeSiders HF Gutta Percha 30/04 |
| 00766054002826 | SafeSiders HF Gutta Percha 25/04 |
| 00766054002819 | Safesider HF Glidepath Refill 25 mm |
| 00766054002802 | Safesider HF Shaper Refill 25 mm |
| 00766054002796 | Safesider HF Finisher Refill 25 mm |
| 00766054002789 | Safesider HF Finisher Refill 21 mm |
| 00766054002772 | Safesider HF Shaper Refill 21 mm |
| 00766054002765 | Safesider HF Glidepath Refill 21 mm |
| 00766054002758 | Safesider HF Intro Kit 25 mm |
| 00766054002741 | Safesider HF Intro Kit 21 mm |