Regisil® Vinyl Polysiloxane Bite Impression Material 619130
GUDID D002619130102
Regisil® VPS Bite Reg Material (Purple), Standard Package
DENTSPLY INTERNATIONAL INC.
Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material| Primary Device ID | D002619130102 |
| NIH Device Record Key | 9ee39b5b-7bad-4386-9cee-624029afb50e |
| Commercial Distribution Discontinuation | 2018-11-10 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Regisil® Vinyl Polysiloxane Bite Impression Material |
| Version Model Number | 619130 |
| Catalog Number | 619130 |
| 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 |
Customer Support Contacts
Device Dimensions
| Total Volume | 90 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 90 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 90 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 90 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 90 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 90 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 90 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 90 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 90 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 90 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 90 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 90 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 90 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 90 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 90 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 90 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 90 Milliliter |
| Device Size Text, specify | 0 |
| Total Volume | 90 Milliliter |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D0026191300 [Primary] |
| HIBCC | D002619130102 [Package] Contains: D0026191300 Package: Box [10 Units] Discontinued: 2018-11-08 Not in Commercial Distribution |
FDA Product Code
| ELW | MATERIAL, IMPRESSION |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2024-01-30 |
| Device Publish Date | 2016-09-21 |
Devices Manufactured by DENTSPLY INTERNATIONAL INC.
| D0026077000 - Calibra® Abutment | 2024-05-03 Calibra® Abutment Resin Cement Syringe Refill |
| D0026077010 - Calibra® Abutment | 2024-05-03 Calibra® Abutment Resin Cement Sample |
| D0026690011 - SmartCem®2 Self-Adhesive Cement | 2024-05-03 SmartCem®2 Self-Adhesive Cement Syringe Introductory Kit |
| D0026690031 - SmartCem®2 Self-Adhesive Cement | 2024-05-03 SmartCem®2 Self-Adhesive Cement Syringe Evaluator Kit |
| D0026070711 - Calibra® Esthetic Resin Cement | 2024-05-02 Calibra® Esthetic Resin Cement, Try-In Paste, Light, 2 (1.8g) syringe Refill Package |
| D0026070721 - Calibra® Esthetic Resin Cement | 2024-05-02 Calibra® Esthetic Resin Cement, Try-In Paste, Medium, 2 (1.8g) syringe Refill Package |
| D0026070731 - Calibra® Esthetic Resin Cement | 2024-05-02 Calibra® Esthetic Resin Cement, Try-In Paste, Dark, 2 (1.8g) syringe Refill Package |
| D0026070741 - Calibra® Esthetic Resin Cement | 2024-05-02 Calibra® Esthetic Resin Cement, Try-In Paste, Translucent, 2 (1.8g) syringe Refill Package |
Trademark Results [Regisil]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 REGISIL 73433028 1284061 Live/Registered |
Dentsply International Inc. 1983-07-01 |
 REGISIL 72306692 0874108 Live/Registered |
REGIS CHEMICAL COMPANY 1968-09-05 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.