| Primary Device ID | 00766054002086 |
| NIH Device Record Key | e14643d5-f0d4-4ab6-8d80-d2f03080bd36 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Flexi-Flange |
| Version Model Number | 445-03 |
| Catalog Number | 445-03 |
| 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 | false |
| Serial Number | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00766054002086 [Primary] |
| ELR | POST, ROOT CANAL |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00766054002086]
Moist Heat or Steam Sterilization
[00766054002086]
Moist Heat or Steam Sterilization
[00766054002086]
Moist Heat or Steam Sterilization
[00766054002086]
Moist Heat or Steam Sterilization
[00766054002086]
Moist Heat or Steam Sterilization
[00766054002086]
Moist Heat or Steam Sterilization
[00766054002086]
Moist Heat or Steam Sterilization
[00766054002086]
Moist Heat or Steam Sterilization
[00766054002086]
Moist Heat or Steam Sterilization
[00766054002086]
Moist Heat or Steam Sterilization
[00766054002086]
Moist Heat or Steam Sterilization
[00766054002086]
Moist Heat or Steam Sterilization
[00766054002086]
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 |
| 00766054002178 | Flexi-Flange Depth Gauge |
| 00766054002123 | Flexi-Flange Refill Size 3 Titanium |
| 00766054002116 | Flexi-Flange Refill Size 2 Titanium |
| 00766054002109 | Flexi-Flange Refill Size 1 Titanium |
| 00766054002093 | Flexi-Flange Refill Size 0 Titanium |
| 00766054002086 | Flexi-Flange Economy Refill Size 3 Titanium |
| 00766054002079 | Flexi-Flange Economy Refill Size 2 Titanium |
| 00766054002062 | Flexi-Flange Economy Refill Size 0 Titanium |
| 00766054002055 | Flexi-Flange Economy Refill Size 1 Titanium |
| 00766054002048 | Flexi-Flange Economy Refill Size 3 Stainless Steel |
| 00766054002031 | Flexi-Flange Economy Refill Size 2 Stainless Steel |
| 00766054002024 | Flexi-Flange Economy Refill Size 1 Stainless Steel |
| 00766054002017 | Flexi-Flange Economy Refill Size 0 Stainless Steel |
| 00766054002000 | Flexi-Flange Refill Size 3 Stainless Steel |
| 00766054001997 | Flexi-Flange Refill Size 2 Stainless Steel |
| 00766054001980 | Flexi-Flange Refill Size 1 Stainless Steel |
| 00766054001973 | Flexi-Flange Refill Size 0 Stainless Steel |
| 00766054001966 | Flexi-Flange Intro Kit Titanium |
| 00766054001959 | Flexi-Flange Intro Kit Stainless Steel |
| 00766054002659 | Flexi-Flange Mini Sterilization Box Complete Titanium (8 Posts) |
| 00766054002642 | Flexi-Flange Mini Sterilization Box Complete Stainless Steel (8 Posts) |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() FLEXI-FLANGE 77166203 3365138 Live/Registered |
DNI REALTY, LLC 2007-04-26 |