DEVICE: SciPharm Copal Cavity Varnish (D801SP7103N1)
Device Identifier (DI) Information
SciPharm Copal Cavity Varnish
SP 71-03 N
In Commercial Distribution
71-03
SCIENTIFIC PHARMACEUTICALS, INC.
SP 71-03 N
In Commercial Distribution
71-03
SCIENTIFIC PHARMACEUTICALS, INC.
Universal Copal Cavity Varnish was formulated to protect dentin from acids released by filling materials. Provides a chemical and thermal barrier while eliminating air pockets. Trial Size. Non-Boxed.
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 [?] |
---|---|
K800438 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: less than 75 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
c4e3705d-92f7-4880-a2e7-200f83bd55d7
July 06, 2018
3
August 11, 2016
July 06, 2018
3
August 11, 2016
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 |
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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
[?]
800-634-3047
Denise@scipharm.com 909-595-9922
Denise@scipharm.com
Denise@scipharm.com 909-595-9922
Denise@scipharm.com