DEVICE: SciPharm Gel Etch Dental Conditioner (D801SP70143N1)

Device Identifier (DI) Information

SciPharm Gel Etch Dental Conditioner
SP 70-143 N
In Commercial Distribution
70-143
SCIENTIFIC PHARMACEUTICALS, INC.
D801SP70143N1
HIBCC

1
096010525 *Terms of Use
Gel Etch is a High Viscosity Enamel Etching Agent for All Bonding Purposes. 60 gram Blue Gel Etch Refill Syringe. Non-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 etching solution An acid solution, in liquid or gel form, intended to be used to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant. After application, this device cannot be reused.
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FDA Product Code

[?]
Product Code Product Code Name
EBF Material, Tooth Shade, Resin
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K872569 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

8b8ac62c-4b39-4929-91be-acc6932c1c01
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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