| Primary Device ID | 07640368191366 |
| NIH Device Record Key | 7bc77047-3e11-4cba-b83a-6066daa27103 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | COMPOSITE TIP DISPENSER |
| Version Model Number | 60022485 |
| Company DUNS | 480017482 |
| Company Name | Coltène/Whaledent AG |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
| Phone | +41717575300 |
| info.ch@coltene.com | |
| Phone | +41717575300 |
| info.ch@coltene.com | |
| Phone | +41717575300 |
| info.ch@coltene.com | |
| Phone | +41717575300 |
| info.ch@coltene.com | |
| Phone | +41717575300 |
| info.ch@coltene.com | |
| Phone | +41717575300 |
| info.ch@coltene.com | |
| Phone | +41717575300 |
| info.ch@coltene.com | |
| Phone | +41717575300 |
| info.ch@coltene.com | |
| Phone | +41717575300 |
| info.ch@coltene.com | |
| Phone | +41717575300 |
| info.ch@coltene.com | |
| Phone | +41717575300 |
| info.ch@coltene.com | |
| Phone | +41717575300 |
| info.ch@coltene.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07640368191366 [Primary] |
| EID | Syringe, Restorative And Impression Material |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07640368191366]
Moist Heat or Steam Sterilization
[07640368191366]
Moist Heat or Steam Sterilization
[07640368191366]
Moist Heat or Steam Sterilization
[07640368191366]
Moist Heat or Steam Sterilization
[07640368191366]
Moist Heat or Steam Sterilization
[07640368191366]
Moist Heat or Steam Sterilization
[07640368191366]
Moist Heat or Steam Sterilization
[07640368191366]
Moist Heat or Steam Sterilization
[07640368191366]
Moist Heat or Steam Sterilization
[07640368191366]
Moist Heat or Steam Sterilization
[07640368191366]
Moist Heat or Steam Sterilization
[07640368191366]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-05-16 |
| Device Publish Date | 2022-05-08 |
| 07640181476947 - BRILLIANT EverGlow | 2025-07-16 Univ. Comp B-EA1 |
| 07640181476954 - BRILLIANT EverGlow | 2025-07-16 Univ. Comp B-EA2 |
| 07640181476961 - BRILLIANT EverGlow | 2025-07-16 Univ. Comp B-EA3 |
| 07640181476985 - BRILLIANT EverGlow | 2025-07-16 Univ. Comp B-EB1 |
| J00644400 - PSI | 2025-06-16 |
| 07640181476879 - BRILLIANT Bulk Fill Flow | 2025-05-07 Brilliant Bulk Fill Flow Sample |
| 07640181476886 - BRILLIANT Bulk Fill Flow | 2025-05-07 BRILLIANT Bulk Fill Flow |
| J0006600332800 - BRILLIANT Bulk Fill Flow | 2024-09-30 |