DEVICE: DFV Desensitizing Varnish (Wonderful Varnish) Chocolate (D801SP70231)
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Device Identifier (DI) Information
DFV Desensitizing Varnish (Wonderful Varnish) Chocolate
70-23
Not in Commercial Distribution
70-23
SCIENTIFIC PHARMACEUTICALS, INC.
70-23
Not in Commercial Distribution
70-23
SCIENTIFIC PHARMACEUTICALS, INC.
DFV Desensitizing Varnish (Wonderful Varnish), Chocolate flavor, is a fluoride-containing resin preparation for the treatment of dentinal hypersensitivity and for the reduction of post-operative sensitivity.
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| Yes | |
| Yes | |
| No | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 35698 | Dental cavity varnish |
A liquid substance used in dentistry consisting of one or more resins in an organic solvent, used for the protection of pulpal tissue and to provide a marginal seal to newly placed amalgam restorations. After application, this device cannot be reused.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| LBH | Varnish, Cavity |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K192381 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Storage Environment Temperature: less than 73 Degrees Fahrenheit |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
cdd7aace-80f6-4ae7-9318-c875f8f6368e
December 25, 2023
2
January 19, 2022
December 25, 2023
2
January 19, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
9095959922
Denise@scipharm.com
Denise@scipharm.com