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Riva Lc

FDA UDI

Class II (US FDA UDI)

by Sdi , Ltd.

Identity

Trade Name
RIVA LC FDA UDI
Generic Name
Glass ionomer dental cement FDA UDI
Device Name
RIVA LC HV A3.5 50 CAP FDA UDI
Model / Reference
8730004 FDA UDI
Description
RIVA LC HV A3.5 50 CAP FDA UDI

Identifiers

Catalog Number
8730004 FDA UDI
Primary DI / UDI-DI
09336472018177 FDA UDI
510(k) Number
K050870 FDA UDI
FDA Product Code
EMA FDA UDI
GMDN Term
Glass ionomer dental cement FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3275 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Glass ionomer dental cement

RIVA LC HV A3.5 50 CAP is a glass ionomer dental cement designed for professional use as a non-sterile substance intended for professional use in dentistry, particularly for direct restorative and luting applications. It features a unique combination of setting reactions based on an aluminosilicate glass powder and an aqueous solution of a polyalkenoic acid.

Similar devices

Also classified as Glass ionomer dental cement.

Cleared under the same submission

K050870 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sdi , Ltd.

Sources (1)

  • FDA UDI c434446b-0c4c-447d-bfb1-dba4a9c024e6 36 fields · synced Jun 28, 2026