DEVICE: SciPharm Fluoroseal Cavity Liner (D801SP75131BS1)

Device Identifier (DI) Information

SciPharm Fluoroseal Cavity Liner
SP 75-131 BS
In Commercial Distribution
75-131
SCIENTIFIC PHARMACEUTICALS, INC.
D801SP75131BS1
HIBCC

1
096010525 *Terms of Use
Fluoroseal is a Light-Cured Cavity Liner used for Building the Cavity Floor in Deep Restorations. Also Provide Protection Against Irritants from Restoratives or Auxiliary Materials. Contrast Shade Syringe. Boxed. Spanish.
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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 cavity varnish A liquid substance used in dentistry consisting of one or more resins in an organic solvent, used for the protection of pulpal tissue and to provide a marginal seal to newly placed amalgam restorations. After application, this device cannot be reused.
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FDA Product Code

[?]
Product Code Product Code Name
LBH Varnish, Cavity
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K860633 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

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

7f4d427d-24c2-423a-9b57-6560ddb2147c
July 06, 2018
3
August 11, 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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