Riva Protect
FDA 510(k) K050871 · Southern Dental Industries, Inc.
510(k) numberK050871
Submission
- Device name
- Riva Protect
- Applicant
- Southern Dental Industries, Inc.
Bayswater Vi 3125, AU - Received
- April 6, 2005
- Decision date
- June 10, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K190339 | Helioseal F PlusEBC · Abbreviated | Ivoclar Vivadent, AG | 07/29/2019SE |
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| K171330 | Nanova SealantEBC · Traditional | Nanova Biomaterials, Inc. | 09/08/2017SE |
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More from Premier Dental Company Products
| 510(k) | Device | Decision |
|---|---|---|
| K062065 | Riva Luting PlusEMA · Traditional | 11/15/2006SE |
| K062064 | Riva Bond LCEMA · Traditional | 11/09/2006SE |
| K051008 | SetEMA · Traditional | 06/15/2005SE |
| K050870 | Riva Light CureEMA · Traditional | 06/03/2005SE |
| K050331 | Adhesive 1KLE · Traditional | 03/24/2005SE |
| K042452 | Riva SilverEMA · Traditional | 12/07/2004SE |
| K040393 | Riva LutingEMA · Traditional | 04/30/2004SE |
| K032152 | Benco AdmixEJJ · Traditional | 08/06/2003SE |
| K031658 | Benco SphericalEJJ · Traditional | 07/29/2003SE |
| K030568 | RadiiEBZ · Traditional | 04/24/2003SE |
Questions and answers
When was Riva Protect cleared by the FDA?
Riva Protect (K050871) received a 510(k) decision of Substantially Equivalent on June 10, 2005, 65 days after the submission was received.
What is the product code of K050871?
The FDA product code is EBC – Sealant, Pit And Fissure, And Conditioner, a Class II (moderate risk) device regulated under 21 CFR 872.3765.