| Primary Device ID | 00766054001256 |
| NIH Device Record Key | 848b8839-3db5-4efe-a466-8920a85cf12d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | C-Mor Dental Mirror Handle |
| Version Model Number | 5001-HS |
| Catalog Number | 5001-HS |
| 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 | 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 | 00766054001256 [Primary] |
| EJB | HANDLE, INSTRUMENT, DENTAL |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00766054001256]
Moist Heat or Steam Sterilization
[00766054001256]
Moist Heat or Steam Sterilization
[00766054001256]
Moist Heat or Steam Sterilization
[00766054001256]
Moist Heat or Steam Sterilization
[00766054001256]
Moist Heat or Steam Sterilization
[00766054001256]
Moist Heat or Steam Sterilization
[00766054001256]
Moist Heat or Steam Sterilization
[00766054001256]
Moist Heat or Steam Sterilization
[00766054001256]
Moist Heat or Steam Sterilization
[00766054001256]
Moist Heat or Steam Sterilization
[00766054001256]
Moist Heat or Steam Sterilization
[00766054001256]
Moist Heat or Steam Sterilization
[00766054001256]
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 |
| 00766054002987 - Turbo-CR | 2025-04-14 Mixing Tips |
| 00766054002994 - Turbo-CR | 2025-04-14 Calculus Softener |
| 00766054003007 - Turbo-CR | 2025-04-14 Disposable Fluoride Trays |
| 00766054002949 - BIOSEAL | 2024-11-08 Bioceramic Endodontic Sealer |
| 00766054002970 - BIOSEAL | 2024-11-08 EndoTips |
| 00766054002901 - Bio-LCB | 2022-11-07 Light Cured Base and Liner Syrinageable |
| 00766054002918 - Bio-LCB | 2022-11-07 Light Cured Base and Liner Syrinageable |
| 00766054002925 - Bio-LCB | 2022-11-07 50 Light Cured Base and Liner Syringe Tips |