Nanocomposite Restorative Kit
FDA 510(k) K080480 · Dmg USA, Inc.
510(k) numberK080480
Submission
- Device name
- Nanocomposite Restorative Kit
- Applicant
- Dmg USA, Inc.
Ayer, MA, US - Received
- February 22, 2008
- Decision date
- May 30, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
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| K130580 | Retraction PasteMVL · Traditional | 02/25/2014SE |
| K110759 | TempocemEMB · Abbreviated | 06/10/2011SE |
| K102603 | SA Flowable AdhesiveEBF · Abbreviated | 11/17/2010SE |
| K101710 | Luxatemp Ultra /StarEBG · Abbreviated | 09/28/2010SE |
| K100062 | Infiltration KitEBC · Abbreviated | 03/26/2010SE |
| K093338 | Self Adhesive Composite Luting CementEMA · Abbreviated | 02/12/2010SE |
| K093587 | Dental MercuryELY · Traditional | 01/21/2010SE |
| K081493 | Infiltration KitEBC · Abbreviated | 09/18/2008SE |
Questions and answers
When was Nanocomposite Restorative Kit cleared by the FDA?
Nanocomposite Restorative Kit (K080480) received a 510(k) decision of Substantially Equivalent on May 30, 2008, 98 days after the submission was received.
What is the product code of K080480?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.