Chromaclone 7600
GUDID 00883205033079
Clone Bite Kit
ULTRADENT PRODUCTS, INC.
Silicone dental impression material| Primary Device ID | 00883205033079 |
| NIH Device Record Key | 9962ebe1-ccd5-41c6-af3f-57fd38a0a2cb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Chromaclone |
| Version Model Number | 7600 |
| Catalog Number | 7600 |
| 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 | true |
| 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 |
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 5 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00883205033079 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K024034
FDA Product Code
| ELW | MATERIAL, IMPRESSION |
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 [Chromaclone]
| 00883205107794 | Chromaclone PVS Wash Regular Set Refill |
| 00883205107787 | Chromaclone PVS Wash Regular Set Econo Refill |
| 00883205107770 | Chromaclone PVS Wash Fast Set Refill |
| 00883205107763 | Chromaclone PVS Wash Fast Set Econo Refill |
| 00883205107756 | Chromaclone PVS Super Light Fast Set Refill |
| 00883205107749 | Chromaclone PVS Putty |
| 00883205107732 | Chromaclone PVS Medium Regular Set Refill |
| 00883205107725 | Chromaclone PVS Medium Regular Set Econo Refill |
| 00883205107718 | Chromaclone PVS Medium Fast Set Refill |
| 00883205107701 | Chromaclone PVS Medium Fast Set Econo Refill |
| 00883205107695 | Chromaclone PVS Heavy Regular Set Refill |
| 00883205107688 | Chromaclone PVS Heavy Regular Set Econo Refill |
| 00883205107671 | Chromaclone PVS Heavy Fast Set Refill |
| 00883205107664 | Chromaclone PVS Heavy Fast Set Econo Refill |
| 00883205107657 | Chromaclone Ortho 5-day Refill Extra Fast Set |
| 00883205107640 | Chromaclone Ortho 5-day Kit Extra Fast Set |
| 00883205107633 | Chromaclone 5-day Bubble Gum Refill Fast Set |
| 00883205107626 | Chromaclone 5-day Bubble Gum Kit Fast Set |
| 00883205033079 | Clone Bite Kit |
| 00883205033062 | Chromaclone PVS Putty |
Trademark Results [Chromaclone]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CHROMACLONE 75305574 not registered Dead/Abandoned |
Chroma Graphics, Inc. 1997-06-09 |
 CHROMACLONE 74668013 not registered Dead/Abandoned |
Dai Nippon Insatsu Kabushiki Kaisha 1995-05-01 |
 CHROMACLONE 74417421 1831047 Live/Registered |
Ultradent Products, Inc. 1993-07-22 |
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