DEVICE: RIVA LC (09336472017590)

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Device Record History
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Device Identifier (DI) Information
RIVA LC
8700102
In Commercial Distribution
8700102
SDI LIMITED
09336472017590
GS1

1
753221852 *Terms of Use
RIVA LC A2 PWD REF 15G
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
16704 Glass ionomer dental cement
A non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between an aluminosilicate glass powder and an aqueous solution of a polyalkenoic acid. It typically includes some additional fillers, and may include setting substances that are in the minority (e.g., resin, metal). After application, this device cannot be reused.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
EMA CEMENT, DENTAL
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K050870 000
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Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Storage conditions < 25°C (< 77°F) for liquid refills and P/L kits. Powder refills can be stored at ambient temperature
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
8edcec65-46b8-41d6-9105-a47e871b0580
January 16, 2025
1
January 08, 2025
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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

[?]
No Customer Contact currently defined
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