| Primary Device ID | 00766054003007 | 
| NIH Device Record Key | 892064b0-3cad-479a-9747-f0a82772bd77 | 
| Commercial Distribution Discontinuation | 2025-04-04 | 
| Commercial Distribution Status | Not in Commercial Distribution | 
| Brand Name | Turbo-CR | 
| Version Model Number | 1100-100 | 
| Catalog Number | 1100-100 | 
| Company DUNS | 101147171 | 
| Company Name | ESSENTIAL DENTAL SYSTEMS, INC. | 
| Device Count | 1 | 
| DM Exempt | false | 
| 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 | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00766054003007 [Primary] | 
| KMT | TRAY, FLUORIDE, DISPOSABLE | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2025-04-14 | 
| Device Publish Date | 2025-04-04 | 
| 00766054003007 | Disposable Fluoride Trays | 
| 00766054002994 | Calculus Softener | 
| 00766054002987 | Mixing Tips |