DEVICE: SciPharm Cemper Permanent Dental Cement (D801SP51253B1)

Device Identifier (DI) Information

SciPharm Cemper Permanent Dental Cement
SP 51-253 B
In Commercial Distribution
51-253
SCIENTIFIC PHARMACEUTICALS, INC.
D801SP51253B1
HIBCC

1
096010525 *Terms of Use
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. Dentin Sealer Bottle. Boxed.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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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FDA Product Code

[?]
Product Code Product Code Name
EMA Cement, Dental
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K904024 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: less than 75 Degrees Fahrenheit
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

810581ac-86fa-40d4-b52a-285a730f106e
July 06, 2018
3
August 03, 2016
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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
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
800-634-3047
Denise@scipharm.com
909-595-9922
Denise@scipharm.com
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