DEVICE: SciPharm Glasion Glass Ionomer Liquid Bottle, Non-Boxed (D801SP500321)
Device Identifier (DI) Information
SciPharm Glasion Glass Ionomer Liquid Bottle, Non-Boxed
SP 50-032
In Commercial Distribution
50-032
SCIENTIFIC PHARMACEUTICALS, INC.
SP 50-032
In Commercial Distribution
50-032
SCIENTIFIC PHARMACEUTICALS, INC.
Glass Ionomer Restorative, Liner, and Cement
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? |
---|---|---|---|---|
16704 | Glass ionomer dental cement |
A non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between an aluminosilicate glass powder and an aqueous solution of a polyalkenoic acid. It typically includes some additional fillers, and may include setting substances that are in the minority (e.g., resin, metal). After application, this device cannot be reused.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EMA | Cement, Dental |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K915376 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: less than 75 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
2ce81549-d47b-4ebd-8c9a-f2456f2de441
July 06, 2018
3
July 07, 2016
July 06, 2018
3
July 07, 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 |
---|---|
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