Thermo Clone 4327
GUDID 00883205033697
Thermo Clone VPS Alginate Alternative 2x50 ml Kit
ULTRADENT PRODUCTS, INC.
Silicone dental impression material| Primary Device ID | 00883205033697 |
| NIH Device Record Key | 5215cfb8-deb0-4ef3-9d5d-2c9ef82657e9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Thermo Clone |
| Version Model Number | 4327 |
| Catalog Number | 4327 |
| 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 | 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 | |
| Phone | +1(801)572-4200 |
| customerservice@ultradent.com | |
| Phone | +1(801)572-4200 |
| customerservice@ultradent.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00883205033697 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K082157
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 | 2023-02-17 |
| Device Publish Date | 2023-02-09 |
On-Brand Devices [Thermo Clone]
| 00883205105387 | Thermo Clone VPS Dynamic Mixer 50ct |
| 00883205105370 | Thermo Clone VPS Tray Adhesive 10ml |
| 00883205027375 | Thermo Clone VPS Fast Set Heavy 10x50 ml Bulk Pack |
| 00883205027368 | Thermo Clone VPS Fast Set Light Body 10x50 ml Bulk Pack |
| 00883205032430 | Thermo Clone VPS Clear Bite Registration Fast Set 2x50 ml Kit |
| 00883205033710 | Thermo Clone VPS Fast Alginate Alternative 380 ml Kit |
| 00883205033703 | Thermo Clone VPS Alginate Alternative 10x50 ml Bulk Pack |
| 00883205033697 | Thermo Clone VPS Alginate Alternative 2x50 ml Kit |
| 00883205031693 | Thermo Clone VPS Dynamic Mixer 50ct |
| 00883205031686 | Thermo Clone VPS Tray Adhesive 10ml |
Trademark Results [Thermo Clone]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 THERMO CLONE 86722999 5214615 Live/Registered |
Ultradent Products, Inc. 2015-08-12 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.