| Primary Device ID | 00766054000259 |
| NIH Device Record Key | d81116ff-4bf6-43e7-98b5-b993a2282de6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EZ-Fill Bi-Directional Spiral |
| Version Model Number | 1600-21 |
| Catalog Number | 1600-21 |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
| 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 | |
| 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 | |
| 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 | 00766054000259 [Primary] |
| DZA | DRILL, DENTAL, INTRAORAL |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00766054000259]
Moist Heat or Steam Sterilization
[00766054000259]
Moist Heat or Steam Sterilization
[00766054000259]
Moist Heat or Steam Sterilization
[00766054000259]
Moist Heat or Steam Sterilization
[00766054000259]
Moist Heat or Steam Sterilization
[00766054000259]
Moist Heat or Steam Sterilization
[00766054000259]
Moist Heat or Steam Sterilization
[00766054000259]
Moist Heat or Steam Sterilization
[00766054000259]
Moist Heat or Steam Sterilization
[00766054000259]
Moist Heat or Steam Sterilization
[00766054000259]
Moist Heat or Steam Sterilization
[00766054000259]
Moist Heat or Steam Sterilization
[00766054000259]
Moist Heat or Steam Sterilization
[00766054000259]
Moist Heat or Steam Sterilization
[00766054000259]
Moist Heat or Steam Sterilization
[00766054000259]
Moist Heat or Steam Sterilization
[00766054000259]
Moist Heat or Steam Sterilization
[00766054000259]
Moist Heat or Steam Sterilization
[00766054000259]
Moist Heat or Steam Sterilization
[00766054000259]
Moist Heat or Steam Sterilization
[00766054000259]
Moist Heat or Steam Sterilization
[00766054000259]
Moist Heat or Steam Sterilization
[00766054000259]
Moist Heat or Steam Sterilization
[00766054000259]
Moist Heat or Steam Sterilization
[00766054000259]
Moist Heat or Steam Sterilization
[00766054000259]
Moist Heat or Steam Sterilization
[00766054000259]
Moist Heat or Steam Sterilization
[00766054000259]
Moist Heat or Steam Sterilization
[00766054000259]
Moist Heat or Steam Sterilization
[00766054000259]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-07-20 |
| Device Publish Date | 2020-07-10 |
| 00766054000303 | EZ-Fill Bi-Directional Spiral 21mm & 25mm Nickel Titanium |
| 00766054000297 | EZ-Fill Bi-Directional Spiral 25mm Nickel Titanium |
| 00766054000280 | EZ-Fill Bi-Directional Spiral 21mm Nickel Titanium |
| 00766054000273 | EZ-Fill Bi-Directional Spiral 21mm & 25mm Stainless Steel |
| 00766054000266 | EZ-Fill Bi-Directional Spiral 25mm Stainless Steel |
| 00766054000259 | EZ-Fill Bi-Directional Spiral 21mm Stainless Steel |