File-Eze S127-CE
GUDID 00883205019356
Sample File-Eze CE
ULTRADENT PRODUCTS, INC.
Endodontic reaming aid material| Primary Device ID | 00883205019356 |
| NIH Device Record Key | 4d20999c-b708-48a7-8de6-2dd6d8cc6d86 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | File-Eze |
| Version Model Number | S127-CE |
| Catalog Number | S127-CE |
| Company DUNS | 013369913 |
| Company Name | ULTRADENT PRODUCTS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(801)572-4200 |
| customerservice@ultradent.com | |
| Phone | +1(801)572-4200 |
| customerservice@ultradent.com | |
| Phone | +1(801)572-4200 |
| customerservice@ultradent.com | |
| Phone | +1(801)572-4200 |
| customerservice@ultradent.com | |
| Phone | +1(801)572-4200 |
| customerservice@ultradent.com | |
| Phone | +1(801)572-4200 |
| customerservice@ultradent.com | |
| Phone | +1(801)572-4200 |
| customerservice@ultradent.com | |
| Phone | +1(801)572-4200 |
| customerservice@ultradent.com | |
| Phone | +1(801)572-4200 |
| customerservice@ultradent.com | |
| Phone | +1(801)572-4200 |
| customerservice@ultradent.com | |
| Phone | +1(801)572-4200 |
| customerservice@ultradent.com | |
| Phone | +1(801)572-4200 |
| customerservice@ultradent.com | |
| Phone | +1(801)572-4200 |
| customerservice@ultradent.com | |
| Phone | +1(801)572-4200 |
| customerservice@ultradent.com | |
| Phone | +1(801)572-4200 |
| customerservice@ultradent.com | |
| Phone | +1(801)572-4200 |
| customerservice@ultradent.com | |
| Phone | +1(801)572-4200 |
| customerservice@ultradent.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 18 Degrees Celsius and 29 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 29 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 29 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 29 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 29 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 29 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 29 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 29 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 29 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 29 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 29 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 29 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 29 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 29 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 29 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 29 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 29 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00883205019356 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K060335
FDA Product Code
| KJJ | CLEANSER, ROOT CANAL |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-10-01 |
| Device Publish Date | 2018-08-31 |
On-Brand Devices [File-Eze]
| 00883205105875 | File-Eze IndiSpense Refill |
| 00883205103956 | File-Eze Kit |
| 00883205103468 | File-Eze Refill |
| 00883205019356 | Sample File-Eze CE |
Trademark Results [File-Eze]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FILE-EZE 74237678 1714978 Live/Registered |
Ultradent Products, Inc. 1992-01-14 |
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