DEVICE: SciPharm Pit & Fissure Sealer Bonding Agent (D801SP53011)

Device Identifier (DI) Information

SciPharm Pit & Fissure Sealer Bonding Agent
SP 53-01
In Commercial Distribution
53-01
SCIENTIFIC PHARMACEUTICALS, INC.
D801SP53011
HIBCC

1
096010525 *Terms of Use
Self-Cured Resin for Sealing Occlusal Fissures and Bonding Composite Restoratives to Etched Enamel. Clear.
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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 pit/fissure sealant A resin-based dental material suitable for sealing pits and fissures on teeth. It may be chemically cured or external energy cured. After application, this device cannot be reused.
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FDA Product Code

[?]
Product Code Product Code Name
EBC Sealant, Pit And Fissure, And Conditioner
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K790788 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 73 Degrees Fahrenheit
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

f4ce7c7c-848d-4859-96d4-03cc3a6b2094
July 06, 2018
3
August 05, 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

[?]
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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