Z-Prime Plus B-6002P
GUDID D757B6002P1
Z-Prime Plus 2ml BTL Pkg
BISCO INC.
Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent| Primary Device ID | D757B6002P1 |
| NIH Device Record Key | 041a5bdd-1279-48d3-ba33-5fc96e863650 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Z-Prime Plus |
| Version Model Number | B-6002P |
| Catalog Number | B-6002P |
| Company DUNS | 053529939 |
| Company Name | BISCO 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 | 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 |
Customer Support Contacts
| Phone | +1(847)534-6000 |
| sales@bisco.com | |
| Phone | +1(847)534-6000 |
| sales@bisco.com | |
| Phone | +1(847)534-6000 |
| sales@bisco.com | |
| Phone | +1(847)534-6000 |
| sales@bisco.com | |
| Phone | +1(847)534-6000 |
| sales@bisco.com | |
| Phone | +1(847)534-6000 |
| sales@bisco.com | |
| Phone | +1(847)534-6000 |
| sales@bisco.com | |
| Phone | +1(847)534-6000 |
| sales@bisco.com | |
| Phone | +1(847)534-6000 |
| sales@bisco.com | |
| Phone | +1(847)534-6000 |
| sales@bisco.com | |
| Phone | +1(847)534-6000 |
| sales@bisco.com | |
| Phone | +1(847)534-6000 |
| sales@bisco.com | |
| Phone | +1(847)534-6000 |
| sales@bisco.com | |
| Phone | +1(847)534-6000 |
| sales@bisco.com | |
| Phone | +1(847)534-6000 |
| sales@bisco.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D757B6002P1 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K091705
FDA Product Code
| KLE | AGENT, TOOTH BONDING, RESIN |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2022-05-18 |
| Device Publish Date | 2017-06-12 |
On-Brand Devices [Z-Prime Plus]
| D757B6003PS1 | Z-Prime Plus .5ml SMPL Pkg |
| D757B6002P1 | Z-Prime Plus 2ml BTL Pkg |
| D757B60020 | Z-Prime Plus 2ml Single BTL |
| D757B6001P1 | Z-Prime Plus 4ml BTL Pkg |
| D757B60010 | Z-Prime Plus 4ml Single BTL |
| D757B6003S0 | Z-Prime Plus 0.5ml BTL SMPL |
| 00810111540056 | Z-Prime Plus 4ml Single BTL |
| 10810111540053 | Z-Prime Plus 4ml BTL Pkg |
| 10810111540060 | Z-Prime Plus 2ml BTL Pkg |
| 00810111540063 | Z-Prime Plus 2ml Single BTL |
| 10810111540077 | Z-Prime Plus 0.5ml BTL SMPL |
Trademark Results [Z-Prime Plus]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 Z-PRIME PLUS 77819438 3955425 Live/Registered |
Bisco, Inc. 2009-09-03 |
 Z-PRIME PLUS 77819410 3951670 Live/Registered |
Bisco, Inc. 2009-09-03 |
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