| Primary Device ID | 00766054002840 |
| NIH Device Record Key | 99a3848c-cc8a-4cb2-b6a7-245055c0ab5b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Endo CSV |
| Version Model Number | 5100-RH |
| Catalog Number | 5100-RH |
| 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 | 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 | |
| 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 | 00766054002840 [Primary] |
| EKX | Handpiece, direct drive, ac-powered |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00766054002840]
Moist Heat or Steam Sterilization
[00766054002840]
Moist Heat or Steam Sterilization
[00766054002840]
Moist Heat or Steam Sterilization
[00766054002840]
Moist Heat or Steam Sterilization
[00766054002840]
Moist Heat or Steam Sterilization
[00766054002840]
Moist Heat or Steam Sterilization
[00766054002840]
Moist Heat or Steam Sterilization
[00766054002840]
Moist Heat or Steam Sterilization
[00766054002840]
Moist Heat or Steam Sterilization
[00766054002840]
Moist Heat or Steam Sterilization
[00766054002840]
Moist Heat or Steam Sterilization
[00766054002840]
Moist Heat or Steam Sterilization
[00766054002840]
Moist Heat or Steam Sterilization
[00766054002840]
Moist Heat or Steam Sterilization
[00766054002840]
Moist Heat or Steam Sterilization
[00766054002840]
Moist Heat or Steam Sterilization
[00766054002840]
Moist Heat or Steam Sterilization
[00766054002840]
Moist Heat or Steam Sterilization
[00766054002840]
Moist Heat or Steam Sterilization
[00766054002840]
Moist Heat or Steam Sterilization
[00766054002840]
Moist Heat or Steam Sterilization
[00766054002840]
Moist Heat or Steam Sterilization
[00766054002840]
Moist Heat or Steam Sterilization
[00766054002840]
Moist Heat or Steam Sterilization
[00766054002840]
Moist Heat or Steam Sterilization
[00766054002840]
Moist Heat or Steam Sterilization
[00766054002840]
Moist Heat or Steam Sterilization
[00766054002840]
Moist Heat or Steam Sterilization
[00766054002840]
Moist Heat or Steam Sterilization
[00766054002840]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-07-27 |
| Device Publish Date | 2020-07-17 |
| 00766054002857 | Endo CSV LED Light |
| 00766054002840 | Endo CSV Replacement Head |
| 00766054002734 | Endo CSV Hand Piece with 25 mm Instruments |
| 00766054002727 | Endo CSV Hand Piece with 21 mm Instruments |
| 00766054002710 | Endo CSV Hand Piece |