DEVICE: SciPharm Cure-On Touch Orthodontic Adhesive (D801SP65021N1)

Device Identifier (DI) Information

SciPharm Cure-On Touch Orthodontic Adhesive
SP 65-021 N
In Commercial Distribution
65-021
SCIENTIFIC PHARMACEUTICALS, INC.
D801SP65021N1
HIBCC

1
096010525 *Terms of Use
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. 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
Dentine adhesive A material primarily used as a bonding-promoting substance between dentine and a composite filling, restorative or luting material. It may also be used as a bonding substance to enamel. After application, this device cannot be reused.
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FDA Product Code

[?]
Product Code Product Code Name
DYH Adhesive, Bracket And Tooth Conditioner, Resin
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K791132 000
No CLOSE

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

51454203-39a2-462b-aa8e-97a4c7e21275
July 06, 2018
3
August 10, 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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