FluoroCal B-30504K
GUDID 00810111542890
FluoroCal 50ct Unit Dose Pkg Green Apple
BISCO INC.
Dental coating, tooth-desensitizing, professional| Primary Device ID | 00810111542890 |
| NIH Device Record Key | 9710f1ab-10dc-4130-acee-5bb7cd310bda |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FluoroCal |
| Version Model Number | B-30504K |
| Catalog Number | B-30504K |
| Company DUNS | 053529939 |
| Company Name | BISCO INC. |
| Device Count | 50 |
| 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 | true |
| 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 | |
| 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 | |
| Phone | +1(847)534-6000 |
| sales@bisco.com | |
| Phone | +1(847)534-6000 |
| sales@bisco.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810111542890 [Unit of Use] |
| GS1 | 10810111542897 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K182917
FDA Product Code
| LBH | Varnish, Cavity |
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 | 2023-12-19 |
| Device Publish Date | 2023-12-11 |
On-Brand Devices [FluoroCal]
| D757B30010 | FluoroCal Unit Dose (.4ml) |
| D757B30501K1 | FluoroCal 50ct Unit Dose Pkg |
| 00810111542548 | FluoroCal 50ct Unit Dose Pkg Spearmint |
| 00810111542890 | FluoroCal 50ct Unit Dose Pkg Green Apple |
| 00810111542876 | FluoroCal 50ct Unit Dose Pkg Bubble Gum |
| 00810111542913 | FluoroCal - 48ct Unit Dose Pkg Assorted: 16 UDs of each flavor (Bubble Gum, Green Apple, & Spea |
| 00810111542906 | FluoroCal - 3 Unit Dose Sample Pkg Assorted: 1 UDs of each flavor (Bubble Gum, Green Apple, & S |
Trademark Results [FluoroCal]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FLUOROCAL 88721166 not registered Live/Pending |
Bisco Inc. 2019-12-10 |
 FLUOROCAL 87094228 not registered Live/Pending |
Bisco, Inc. 2016-07-06 |
 FLUOROCAL 75755818 2545718 Live/Registered |
Acton Technologies, Inc. 1999-07-20 |
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