Nanova Sealant
FDA 510(k) K171330 · Nanova Biomaterials, Inc.
510(k) numberK171330
Submission
- Device name
- Nanova Sealant
- Applicant
- Nanova Biomaterials, Inc.
Columbia, MO, US - Received
- May 5, 2017
- Decision date
- September 8, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K161580 | Premier SealantEBC · Traditional | Premier Dental Company Products | 10/18/2016SE |
| K141717 | Pacseal Pit & Fissure SealantEBC · Traditional | Pac-Dent International, Inc. | 03/09/2015SE |
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| K161174 | Nanova Interference ScrewMAI · Traditional | 11/03/2016SE |
| K151943 | Vas-Q-ClipFZP · Traditional | 03/25/2016SE |
| K152004 | Nanova Universal CompositeEBF · Traditional | 11/17/2015SE |
| K150623 | Nanova Flowable CompositeEBF · Traditional | 06/18/2015SE |
| K140349 | Starbright 5% Sodium Fluoride VarnishLBH · Traditional | 09/22/2014SE |
Questions and answers
When was Nanova Sealant cleared by the FDA?
Nanova Sealant (K171330) received a 510(k) decision of Substantially Equivalent on September 8, 2017, 126 days after the submission was received.
What is the product code of K171330?
The FDA product code is EBC – Sealant, Pit And Fissure, And Conditioner, a Class II (moderate risk) device regulated under 21 CFR 872.3765.