Enamelast 4821
GUDID 00883205029072
Enamelast Variety 200pk – Caramel
ULTRADENT PRODUCTS, INC.
Dental coating, tooth-desensitizing, professional| Primary Device ID | 00883205029072 |
| NIH Device Record Key | e7fed785-9071-4696-b769-11be798d0be8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Enamelast |
| Version Model Number | 4821 |
| Catalog Number | 4821 |
| 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 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00883205029072 [Primary] |
FDA Product Code
| LBH | VARNISH, CAVITY |
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 | 2022-09-06 |
| Device Publish Date | 2022-08-29 |
On-Brand Devices [Enamelast]
| 00883205107923 | Enamelast Unit Dose 50pk - Walterberry |
| 00883205107916 | Enamelast 200pk Walterberry |
| 00883205103314 | Enamelast 0.4ml Syringe 200pk - Walterberry |
| 00883205103185 | Enamelast Syringe 2pk - Walterberry |
| 00883205103178 | Enamelast Syringe 20pk - Walterberry |
| 00883205102928 | Enamelast Unit Dose 200pk - Variety Pack |
| 00883205102911 | Enamelast Syringe 20pk - Bubble Gum |
| 00883205102904 | Enamelast Syringe 2pk - Bubble Gum |
| 00883205102898 | Enamelast Unit Dose 5pk - Bubble Gum |
| 00883205102881 | Enamelast Unit Dose 50pk - Bubble Gum |
| 00883205102874 | Enamelast Unit Dose 200pk - Bubble Gum |
| 00883205102867 | Enamelast Syringe 20pk - Cool Mint |
| 00883205102850 | Enamelast Syringe 2pk - Cool Mint |
| 00883205102843 | Enamelast Unit Dose 5pk - Cool Mint |
| 00883205102836 | Enamelast Unit Dose 50pk - Cool Mint |
| 00883205102829 | Enamelast Unit Dose 200pk - Cool Mint |
| 00883205102812 | Enamelast Syringe 20pk - Orange Cream |
| 00883205102805 | Enamelast Syringe 2pk - Orange Cream |
| 00883205102799 | Enamelast Unit Dose 5pk - Orange Cream |
| 00883205102782 | Enamelast Unit Dose 50pk - Orange Cream |
| 00883205102775 | Enamelast Unit Dose 200pk - Orange Cream |
| 00883205102751 | Sample Enamelast Walterberry |
| 00883205101754 | Enamelast Unit Dose 5pk - Walterberry |
| 00883205021533 | Enamelast 200pk Application Brushes |
| 00883205033314 | Enamelast Unit Dose 50pk Flavor Free |
| 00883205033307 | Enamelast Unit Dose 200pk Flavor Free |
| 00883205029089 | Enamelast Caramel 200pk |
| 00883205029072 | Enamelast Variety 200pk – Caramel |
| 00883205028464 | Enamelast Unit Dose 50pk - Caramel |
| 00883205032171 | Enamelast 200pk Application Brushes |
Trademark Results [Enamelast]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENAMELAST 85781528 4580911 Live/Registered |
Ultradent Products, Inc. 2012-11-16 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.