DEVICE: SciPharm Luster Polishing Paste, Non-Boxed (D801SP50051N1)

Device Identifier (DI) Information

SciPharm Luster Polishing Paste, Non-Boxed
SP 50-051 N
In Commercial Distribution
50-051
SCIENTIFIC PHARMACEUTICALS, INC.
D801SP50051N1
HIBCC

1
096010525 *Terms of Use
Dental Polishing Paste for Composite Restoratives, Amalgams, and Castings.
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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
Dentifrice A substance, or combination of substances, intended to be used for cleaning the accessible surfaces of the teeth by polishing. It typically includes mild abrasives, detergents, flavouring agents, and other products, and is normally supplied as a toothpaste or tooth powder intended for self-application using a toothbrush, or formulated to be applied by dental professionals using a handpiece attachment. After application, this device cannot be reused.
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FDA Product Code

[?]
Product Code Product Code Name
EJR Agent, Polishing, Abrasive, Oral Cavity
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 15 and 83 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

9df64573-7d4a-4830-9595-c9a272499478
March 29, 2018
2
July 08, 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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