DEVICE: SciPharm Cemper Permanent Dental Cement (D801SP51252B1)
Device Identifier (DI) Information
SciPharm Cemper Permanent Dental Cement
SP 51-252 B
In Commercial Distribution
51-252
SCIENTIFIC PHARMACEUTICALS, INC.
SP 51-252 B
In Commercial Distribution
51-252
SCIENTIFIC PHARMACEUTICALS, INC.
Cemper Permanent Crown and Bridge Cements and is a luting agent based on polymer resins. Physical properties are optimized for better working time, ease of placement, and longevity in the oral environment. Part B. Boxed.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
---|---|---|---|---|
35870 | Dental composite resin |
A non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. 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 [?] |
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K904024 | 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
c611221c-4628-4a66-8158-db0a3072ab0a
July 06, 2018
3
August 03, 2016
July 06, 2018
3
August 03, 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 |
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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