| Primary Device ID | D0026306540 |
| NIH Device Record Key | c0c679ea-cc6d-4b4b-9391-61af5ca88ff2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Esthet-X®HD Micro Matrix Restorative Easy-Twist Syringe Translucent Enamel Shade |
| Version Model Number | 630654 |
| Catalog Number | 630654 |
| Company DUNS | 083235549 |
| Company Name | DENTSPLY INTERNATIONAL INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| 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 |
| Device Size Text, specify | 0 |
| Weight | 3 Gram |
| Device Size Text, specify | 0 |
| Weight | 3 Gram |
| Device Size Text, specify | 0 |
| Weight | 3 Gram |
| Device Size Text, specify | 0 |
| Weight | 3 Gram |
| Device Size Text, specify | 0 |
| Weight | 3 Gram |
| Device Size Text, specify | 0 |
| Weight | 3 Gram |
| Device Size Text, specify | 0 |
| Weight | 3 Gram |
| Device Size Text, specify | 0 |
| Weight | 3 Gram |
| Device Size Text, specify | 0 |
| Weight | 3 Gram |
| Device Size Text, specify | 0 |
| Weight | 3 Gram |
| Device Size Text, specify | 0 |
| Weight | 3 Gram |
| Device Size Text, specify | 0 |
| Weight | 3 Gram |
| Device Size Text, specify | 0 |
| Weight | 3 Gram |
| Device Size Text, specify | 0 |
| Weight | 3 Gram |
| Device Size Text, specify | 0 |
| Weight | 3 Gram |
| Device Size Text, specify | 0 |
| Weight | 3 Gram |
| Device Size Text, specify | 0 |
| Weight | 3 Gram |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D0026306540 [Primary] |
| EBF | MATERIAL, TOOTH SHADE, RESIN |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2023-08-31 |
| Device Publish Date | 2016-09-23 |
| D0026306520 | Esthet-X®HD Micro Matrix Restorative, YE, 1 (3g) Easy-Twist Syringe Refill Package |
| D0026306540 | Esthet-X®HD Micro Matrix Restorative, GE, 1 (3g) Easy-Twist Syringe Refill Package |
| D0026306530 | Esthet-X®HD Micro Matrix Restorative, AE, 1 (3g) Easy-Twist Syringe Refill Package |
| D0026306510 | Esthet-X®HD Micro Matrix Restorative, WE, 1 (3g) Easy-Twist Syringe Refill Package |
| D0026306500 | Esthet-X®HD Micro Matrix Restorative, CE, 1 (3g) Easy-Twist Syringe Refill Package |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ESTHET-X 75937000 2440776 Live/Registered |
DENTSPLY SIRONA INC. 2000-03-06 |